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.
Pneumonia aspiration; Vomiting; sputum; queasy; respiratory failure; cardiac function decreased; pyrexia of 39.0-39.9 degrees Celsius; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21125208. A 76-year and 11-month-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) via an unspecified route of administration, on 02Aug2021 at 14:20, at the age of 76-year-old, as dose 2, single, for COVID-19 immunization. Medical history included hemodialysis since 2011 for chronic kidney disease due to type 2 diabetes mellitus. On 26May2021, the patient had strangulation ileus, for which surgery was performed at another hospital. On 07Jun2021, the patient was diagnosed with disuse syndrome. The patient had no family history. Concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, Solution for injection, Lot number and expiration date unknown) via an unspecified route of administration, on 12Jul2021 at 14:20, at the age of 76-year-old, as dose 1, single, for COVID-19 immunization. On 28Jun2021, the patient was transferred to the reporting hospital for rehabilitation. Physiotherapy and occupational therapy were performed. Body temperature before vaccination on 02Aug2021 was 37.6 degrees centigrade. On 02Aug2021 (the day of vaccination), the patient had pyrexia of 39.0-39.9 degrees Celsius, and an antipyretic was used. On 03Aug2021 at 17:00 (one day/2 hours/40 minutes after the vaccination), the patient experienced pneumonia aspiration and vomiting; the patient had sputum, queasy, and vomiting. Thereafter, the patient had respiratory failure and cardiac function decreased. The reporting physician classified the events pneumonia aspiration and vomiting as serious (death) and assessed the causality between the events pneumonia aspiration and vomiting and BNT162B2 as unassessable. Other possible causes of the event such as any other diseases included strangulated ileus and chronic kidney disease. The reporting physician commented as follows: Since admission to the reporting hospital, the patient had never had queasy nor vomiting. However, approximately 15 hours after the second dose of BNT162B2 vaccination, the patient had vomiting, and he also had pneumonia aspiration. On 03Aug2021 at 21:48 (one day/7 hours/28 minutes after vaccination), the patient was confirmed dead. The outcome of the events pneumonia aspiration and vomiting was fatal while it was unknown for the other events. Causes of death were reported as pneumonia aspiration and vomiting. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Pneumonia aspiration; Vomiting
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EY3860 |
| RECVDATE: | 09-07-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 08-03-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:39.0-39.9 Centigrade; Comments: After vaccination |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Chronic kidney disease; Disuse syndrome; Haemodialysis; Occupational therapy; Physiotherapy; Strangulation ileus (surgery was performed); Surgery; Type 2 diabetes mellitus |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101121499 |
| FORM_VERS: | |
| TODAYS_DATE: | 09-06-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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