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.
Agitation; Tachycardia; Sudden death; Fall; This is a spontaneous report from contactable physician downloaded from the Medicines Agency (MA) WEB regulatory authority FR-AFSSAPS-PC20210066. An 82-year-old male patient received bnt162b2 (COMIRNATY, lot/batch EJ6795) intramuscular at single dose on 15Jan2021 for covid-19 immunisation, prednisolone (SOLUPRED) oral from 15Jan2021 to 15Jan2021 at 40 mg for bronchitis, amoxicillin, clavulanic acid (AUGMENTIN) oral from 14Jan2021 to 16Jan2021 at 2 g for bronchitis. Medical history included effort angina (stress angina for more than 20 years), angioplasty on the IVA + stent in 1997, diabetes mellitus insulin-dependent, orthostatic hypotension (low compression refusal), dyslipidemia, stent placement, fall, cognitive disorder, dissociative identity disorder (DID), gastritis, diverticular sigmoiditis in May2018 with enterococcal bacteremia complicated by necrotic esophagitis and shock treated in intensive care, amputation 1st and 2nd phalanx 5th finger right hand, bilateral hip prosthesis, vertebral compression, swallowing disorders. Between 27Jan20 to 28Apr2020: admitted to SSR for treatment of repeated falls (also on 11Dec2021). No brain bleeding on the CT scan. On 20Apr2020 Cardiac ultrasound: Moderately tight aortic stenosis (SA = 1.4 cm?) and calcified. LV of normal size with slightly hypertrophied walls in a concentric way. Global systolic function of LV normal (EF = 61%). Normal LV filling pressures. Discreetly dilated OG. Normal straight cavities. Systolic PAP = 34 mmHg. Normal pericardium. On 30Apr2020 ECG: RSR at 60 / min, full BBG already known. On 05May2020: a documented COVID infection, non-serious form of COVID. Last COVID PCR test 14Dec2020: negative. The last blood test was carried out on 13Jan2021: Kalaemia at 4 mmol/l, Natremia at 145 mmol/l, Creatinemia at 67 micromol/l, CRP at 18, Leukocytes at 10,300 and HB at 13.4 g/dl, platelet at 220 000, Albuminemia at 36 g/l. The patient's concomitant medications included as usual treatments: acetylsalicylic acid (manufacturer unknown) 75 mg 1 sachet in the morning, for 1 month, every day, lansoprazole (manufacturer unknown) 15 mg mg: 1 tab in the morning, for 1 month, every day, atorvastatine (manufacturer unknown) 10 mg tablet: 1 tab in the morning, for 1 month, every day, paracetamol (manufacturer unknown) 500 mg: 1 morning sachet, 1 midday sachet, 1 evening sachet, for 1 month, every day if moderate to light pain, insulin aspart (NOVORAPID) 100 IU/ml: Subcutaneous, 8:00, 12:00, 18:00, according to protocol, for 1 month, every day, zopiclone (IMOVANE) 3.75 mg: 1 tab in the evening, macrogol (MOVICOL) 13.8 g: 2 sachets in the morning, insulin glargine (LANTUS) 100 IU/ml slow-acting solution for injection: Subcutaneous, 20 IU in the morning, for 1 month, every day, risperidone (RISPERDAL) 0.5 mg/d (date of introduction not specified). The patient experienced fall on 15Jan2021, agitation on 16Jan2021, tachycardia on 16Jan2021, sudden death on 16Jan2021. On an unknown date the patient did not eat a lot because they are dissatisfied with the mixed meals set up due to swallowing disorders. Course of events: Due to repeated falls, the patient cannot return home. He was hospitalized in Long Term Care while waiting for a place in Home for Senior and Dependent Persons. On 14Jan2021, due to bronchitis with a fever (maximum 38?C), the patient initiated treatment with AUGMENTIN 1g x2/day and BRICANYL aerosol. On 15Jan2021: 10:30 am administration of the COMIRNATY vaccine. Before vaccination the patient did not appear to be feverish, pulse at 103 / min. At meals, as at breakfast, the patient did not eat a lot because they are dissatisfied with the mixed meals set up due to swallowing disorders. At 1:00 p.m. after the meal, the patient falls from her chair. He rocked back. A priori no notion of head trauma. The Sa O2 was then 91%. At 4 p.m., as part of his bronchitis, the patient received 40 mg of SOLUPRED. During the night of 15Jan2021 to 16Jan2021 the patient was agitated. He "spoke until 2 am". He was also agitated on the morning of 16Jan2021 during his toilet and then in the afternoon. He pulled out his IV. At 8:00 a.m. pulse at 103, BP 118/70 then at 6:00 p.m. pulse at 106/min and BP at 100/55. A BRICANYL aerosol was applied at 7 p.m., lasting 15 minutes. When removing the aerosol, the patient was fine but has just eaten little with his evening meal (a small compote). Patient remained afebrile all day. DEXTRO at 23 mmol/l . At 8:25 p.m.: during his shift, the nurse notices the patient's death in his bed. The action taken in response to the events for bnt162b2 was not applicable, for amoxicillin, clavulanic acid was unknown. It was not reported if an autopsy was performed. The outcome of patient did not eat a lot was unknown, of all other events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death; tachycardia; agitation; fall
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