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.
Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the Regulatory authority; report number is v21122809. A 35-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 02Jul2021 16:00 (Lot Number: FC3661; Expiration Date: 30Sep2021) as dose 2, single (at age of 35-years-old) for covid-19 immunisation. Medical history included intellectual disability and sleep apnoea syndrome. The patient had no relevant family history. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FA2453, Expiration date: 31Aug2021) on 10Jun2021 as a single dose for COVID-19 immunization. On 13Jul2021 at 15:00 (11 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 13Jul2021 at 16:39 (11 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 13Jul2021 at around 15:00, since the patient complained of headache, she took CALONAL 200 mg, 2 tablets, and then went to the restroom. When she returned from the restroom, she lost consciousness and collapsed. An ambulance was called, and she was transferred to a hospital where cardiopulmonary resuscitation was performed. However, at 16:39, the patient passed away. The patient underwent lab tests and procedures which included body temperature: 36.5 centigrade before vaccination on 02Jul2021. Outcome of the event was fatal. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The event occurred 11 days after the second dose of the vaccination, therefore it could not be said that there was no causal relationship.; Reported Cause(s) of Death: Subarachnoid haemorrhage
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FC3661 |
| RECVDATE: | 08-17-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 07-13-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Intellectual disability; Sleep apnoea syndrome |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101023468 |
| FORM_VERS: | |
| TODAYS_DATE: | 08-16-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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