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.
left bundle branch block; she was stressed; sore spot in the left breast; occasional pain at night; Chest discomfort / Chest pain; Tachycardia; Vaccination site pain; Feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: FR-AFSSAPS-ST20221101. A 71-year-old female patient received BNT162b2 (COMIRNATY), on 17Nov2021 as dose 3 (booster), 0.3ml single (Lot number: 1F1019A) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sclerosis multiple" (ongoing). Concomitant medication(s) included: OCREVUS. Vaccination history included: Covid-19 vaccine (DOSE 1, favorable outcome.), for covid-19 immunisation, reaction(s): "Vaccination site pain"; Covid-19 vaccine (DOSE 1, favorable outcome.), for COVID-19 immunisation, reaction(s): "malaise"; Covid-19 vaccine (DOSE 2, favorable outcome.), for COVID-19 immunisation, reaction(s): "Malaise", "Vaccination site pain". The following information was reported: MALAISE (non-serious) with onset 22Nov2021, outcome "recovered", described as "Feeling sick"; VACCINATION SITE PAIN (non-serious) with onset 22Nov2021, outcome "recovered"; CHEST DISCOMFORT (medically significant) with onset Jan2022, outcome "recovering", described as "Chest discomfort / Chest pain"; TACHYCARDIA (medically significant) with onset Jan2022, outcome "recovering"; PAIN (non-serious) with onset 21Apr2022, outcome "unknown", described as "occasional pain at night"; BUNDLE BRANCH BLOCK LEFT (non-serious), outcome "unknown", described as "left bundle branch block"; STRESS (non-serious), outcome "unknown", described as "she was stressed"; BREAST PAIN (non-serious), outcome "unknown", described as "sore spot in the left breast". The event "left bundle branch block" required physician office visit. The event "chest discomfort / chest pain" required emergency room visit. The patient underwent the following laboratory tests and procedures: Heart rate: (09Jan2022) 195, notes: 195bpm during a walk; (21Jan2022) 190, notes: 190 bpm; (21Jan2022) 209, notes: 209 bpm; ergocycle: (06Jan2022) decreased results at the ergocycle.; Radioisotope scan: (18Mar2022) Normal. Clinical course: After each injection (Dose 1, Dose 2 and Booster Dose 1): pain at the vaccination site and malaise, favourable outcome. On 06Jan2022 i.e (that was) 1.5 months after Booster Dose 1: decreased results at the ergocycle. On 09Jan2022, 195 bpm during a walk. consultation with the cardiologist: advice to slow down. On examination, he diagnosed a de novo left bundle branch block and prescribed cardiac scintigraphy. On 21Jan2022: chest pain. Emergency consultation, the doctor confirmed the absence of infarction and the presence of de novo left bundle branch block. Tachycardia between 190 and 209 bpm without particular pain. At night, woke up with a painful spot in the left breast which faded after about an hour. Scintigraphy was performed on 18Mar: result normal. Tachycardia on exertion and occasional pain at night (21Apr2022). The patient asked for the activities she could do despite persistent tachycardia. The secretary responded on behalf of the doctor that she was stressed and needed to do sports. No follow-up attempts are possible. No further information is expected.
| Vaccine Type | Manufacturer | Vaccine Name | Dose | Route | Site | Lot |
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| RECVDATE: | 11 May 2022 |
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| DIED: | |
| DATEDIED: | |
| L_THREAT: | |
| ER_VISIT: | |
| HOSPITAL: | |
| HOSPDAYS: | |
| X_STAY: | |
| DISABLE: | |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20220109; Test Name: Heart rate; Result Unstructured Data: Test Result:195; Comments: 195bpm during a walk; Test Date: 20220121; Test Name: Heart rate; Result Unstructured Data: Test Result:190; Comments: 190 bpm; Test Date: 20220121; Test Name: Heart rate; Result Unstructured Data: Test Result:209; Comments: 209 bpm; Test Date: 20220106; Test Name: ergocycle; Result Unstructured Data: Test Result:decreased results at the ergocycle.; Test Date: 20220318; Test Name: Cardiac scintigraphy; Result Unstructured Data: Test Result:Normal |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | OCREVUS |
| CUR_ILL: | Sclerosis multiple |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | FRPFIZER INC202200656745 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 10 May 2022 |
| BIRTH_DEFECT: | |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: | |
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