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.
light headedness; BP: 82/-; Pallor facial; feeling cold; vagal reflex; Anaphylactic shock; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127606. A 16-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 22Sep2021 16:55 (at the age of 16-year-old) (Batch/Lot Number: FJ7489; Expiration Date: 31Jan2022) as dose 1, single for covid-19 immunisation. The patient had no medical history and no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient's concomitant medications were not reported. Body temperature before vaccination was 36.0 degrees centigrade. The course of the event was as follows: at 16:55, the vaccine was intramuscularly injected (on the patient's left shoulder) at his seat. The patient did not move after the vaccination. At 17:05, the patient experienced light headedness. Blood pressure (BP) was 82/-, pulse (P): 52, and SpO2: 97. Pallor facial and feeling cold that made his t-shirt wet appeared. When the patient's name was called, his response was clear. The patient's legs were elevated. A route for drip infusion was ensured with saline. BP: 90/-, P: 60, and SpO2: 97. Adrenaline 0.3 cc was intramuscularly injected (on the patient's right shoulder). At around 17:10, BP: 105/74, and P: 78. At 17:15, an ambulance was called. The patient's consciousness was clear all the time. The patient's condition was explained to his father. At 17:25, an ambulance arrived. BP: 119/80, P: 94, and SpO2: 98%. The patient was raced to a hospital and was hospitalized on an unspecified date due to the events. A possibility of anaphylactic shock was suspected. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was unknown. The reporter commented as follows: a possibility of vagal reflex also cannot be denied. However, the symptoms appeared while the patient was using his smartphone, and it was difficult to consider that possibility. Outcome of events was unknown.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FJ7489 | OT | LA |
| RECVDATE: | 10-07-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | Test Date: 20210922; Test Name: BP; Result Unstructured Data: Test Result:82/-; Comments: 17:05; Test Date: 20210922; Test Name: BP; Result Unstructured Data: Test Result:90/-; Test Date: 20210922; Test Name: BP; Result Unstructured Data: Test Result:105/74; Comments: 17:10; Test Date: 20210922; Test Name: BP; Result Unstructured Data: Test Result:119/80; Comments: 17:25; Test Date: 20210922; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210922; Test Name: P; Result Unstructured Data: Test Result:52; Comments: 17:05; Test Date: 20210922; Test Name: P; Result Unstructured Data: Test Result:60; Test Date: 20210922; Test Name: P; Result Unstructured Data: Test Result:78; Comments: 17:10; Test Date: 20210922; Test Name: P; Result Unstructured Data: Test Result:94; Comments: 17:25; Test Date: 20210922; Test Name: SPO2; Result Unstructured Data: Test Result:97; Comments: 17:05; Test Date: 20210922; Test Name: SPO2; Result Unstructured Data: Test Result:97; Test Date: 20210922; Test Name: SPO2; Result Unstructured Data: Test Result:98; Comments: 17:25 |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101260627 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-06-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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