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.
She aspirated and she was dead within week on respirator; she aspirated and she had pulmonary problem to begin with; 3 convulsions within 24 hours of having her first Pfizer / three grand mal compulsive seizures; This is a spontaneous report from a contactable physician. A 55-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported, vaccinated at the age of 55 years old) as single dose for covid-19 immunisation. Medical history included epilepsy, myocardial metabolism disorder. She has a myocardial metabolism disorder, very specific one and it is A467T mutation in the polymerase gamma gene and that is because of her epilepsy. It was because of that it's a progressive disease get involved with many part of the body that is all so causes seizure. Concomitant medications included clobazam; lamotrigine; escitalopram; amitriptyline; calcium folinate (LEUCOVORINE); lorazepam; mesalazine; butalbital, caffeine, paracetamol (FIORICET); vitamin b2 [riboflavin] (VITAMIN B2 [RIBOFLAVIN]); ubidecarenone (COQ10 [UBIDECARENONE]); l-carnitine [levocarnitine]; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]); vitamin a [retinol]; vitamin c [ascorbic acid], all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur, nepatop, dilantin [phenytoin], prednisone, and lidocaine and all experienced hypersensitivity. The patient had received 3 convulsions within 24 hours of having her first Pfizer and she had epilepsy like she has been suffering from years and she aspirated and she was dead within week on respirator. She had three grand mal compulsive seizures and because of the seizures; she aspirated and she had pulmonary problem to begin with. She was put on a respirator and she was on respirator from the day she was admitted and she probably died within about two days. when the vaccination was, precise 24 hours later she had three grand mal compulsive seizures and because of the seizures she aspirated and she had pulmonary problem to begin with. She had 3 convulsive seizures that stayed for about 10 minutes and she had not, she normally would have the focal seizure just in her left arm. She has not had it big seizure in probably 20 years. The physician stated that don't know what killed her was not seizure when she wasn't he hospital she was intubated and she was alive. What killed her was she was aspirated and they could not get her off the respirator and she did not have COVID. When she was admitted to the hospital they did a lot of blood test. Before that, her cortisone level usually runs about 200, with metabolize of 700, and her lamotrigine level runs about between 4 and 8.5 of all other routine her Full blood count (CBC) routine is quite normal. It was not reported if an autopsy was performed. Outcome of events Grand mal seizure and Pulmonary disorder was unknown. Information on batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported seizures along with the consequent aspirations which lead to death and the use of BNT162B2 cannot be fully excluded. However, it is noted that the patient has multiple comorbidities which confound the reported drug event pairs. 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.; Reported Cause(s) of Death: She aspirated and she was dead within week on respirator
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|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|LAB_DATA:||Test Name: cortisone level; Result Unstructured Data: Test Result:200; Comments: Her cortisone level usually runs about 200, with metabolize of 700; Test Name: blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: CBC; Result Unstructured Data: Test Result:normal; Test Name: lamotrigine level; Result Unstructured Data: Test Result:4; Comments: her lamotrigine level runs about between 4 and 8.5|
|OTHER_MEDS:||CLOBAZAM; LAMOTRIGINE; ESCITALOPRAM; AMITRIPTYLINE; LEUCOVORINE; LORAZEPAM; MESALAMINE; FIORICET; VITAMIN B2 [RIBOFLAVIN]; COQ10 [UBIDECARENONE]; L-CARNITINE [LEVOCARNITINE]; B COMPLEX [VITAMIN B COMPLEX]; VITAMIN A [RETINOL]; VITAMIN C [AS|
|HISTORY:||Medical History/Concurrent Conditions: Cardiomyopathy (A467T mutation in the polymerase gamma gene); Epilepsy|