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.
cardiovascular accident; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300155182. A 54-year-old male patient received BNT162b2 (COMIRNATY), on 26Aug2022 at 13:34 as dose 3 (booster), single (Lot number: PCB0015, Expiration Date: 22Jul2022) at the age of 54 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series, Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (primary immunization series, Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: CARDIOVASCULAR DISORDER (death) with onset 26Aug2022 at 14:05, outcome "fatal", described as "cardiovascular accident". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (26Aug2022) 130/70; (26Aug2022) 140/80, notes: before vaccination; Body temperature: (26Aug2022) 36.9; (26Aug2022) 36.6, notes: before vaccination; Heart rate: (26Aug2022) 78; (26Aug2022) 95, notes: before vaccination; Oxygen saturation: (26Aug2022) 95; (26Aug2022) 96, notes: before vaccination; Respiratory rate: (26Aug2022) 19; (26Aug2022) 19, notes: before vaccination; Weight: (26Aug2022) 42. Therapeutic measures were taken as a result of cardiovascular disorder. The patient date of death was 26Aug2022. Reported cause of death: "cardiovascular accident". Reviving the patient was continuously done. Hooked to oxygen, intravenous therapy started, 1 ampule epinephrine was given, at around 2:30 PM with no response noted, the patient was declared dead. Clinical course: The client came to the vaccination site in normal condition on August 26, 2022. He sat with other clients in the waiting area waiting for his name to be called. He was No. 19 on the list. After registering his name, he was counseled and taken vital signs with V/S: (BP-140/80, T-36.6, PR-95, RR-19, 02sat- 96, Wt-42). He was extremely willing to have a booster shot because of planning to travel for his son's graduation. After that, he was examined by a doctor for clearance to be vaccinated. He had his first booster dose at 1:34 pm, vaccinated with Pfizer vaccine with Lot# PCB0015 Exp date of July 2022 with an extended shelf life of October 2022 as per dated June 16, 2022. After he was vaccinated, he was advised to take a rest and wait for about 15mins or until his name will be called. His Post-vaccination vital signs that were taken at around 1:49 pm: were BP-130/70, T-36.9, PR-78, RR- 19, and SPO2-95. He was advised to take it slowly going back to their home as the weather was very sunny at that time of the day. At 2:00 pm the client went home by foot together with his nephew. 5minutes walk from the vaccination site, the client complained to his nephew that he was dizzy but upon turning his nephew's head, he was already on the ground. His nephew mentioned that the client fell backward. The client was rescued at 2:05 pm. BP cannot be heard, pulsation was palpatory. CPR did on-site and then transferred to a health station. Reviving the patient was continuously done. Hooked to oxygen, intravenous therapy started, 1 ampule epinephrine was given. at around 2:30 pm with no response noted, the patient was declared dead. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiovascular accident
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(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | PCB0015 | OT | LA |
| RECVDATE: | 09-17-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 08-26-2022 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20220826; Test Name: BP; Result Unstructured Data: Test Result:130/70; Test Date: 20220826; Test Name: BP; Result Unstructured Data: Test Result:140/80; Comments: before vaccination; Test Date: 20220826; Test Name: T; Result Unstructured Data: Test Result:36.9; Test Date: 20220826; Test Name: T; Result Unstructured Data: Test Result:36.6; Comments: before vaccination; Test Date: 20220826; Test Name: PR; Result Unstructured Data: Test Result:78; Test Date: 20220826; Test Name: PR; Result Unstructured Data: Test Result:95; Comments: before vaccination; Test Date: 20220826; Test Name: SPO2; Result Unstructured Data: Test Result:95; Test Date: 20220826; Test Name: SPO2; Result Unstructured Data: Test Result:96; Comments: before vaccination; Test Date: 20220826; Test Name: RR; Result Unstructured Data: Test Result:19; Test Date: 20220826; Test Name: RR; Result Unstructured Data: Test Result:19; Comments: before vaccination; Test Date: 20220826; Test Name: weight; Result Unstructured Data: Test Result:42 |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | PHPFIZER INC202201140317 |
| FORM_VERS: | |
| TODAYS_DATE: | 09-12-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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