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.
Nosebleeds/have had 11 episodes since then. Mostly from the left side, last 20 min to 65 min; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration in left arm on 12Mar2021 at 12:45 (Batch/Lot Number: EN6208) as (At the age of 68-years) dose 1, single for covid-19 immunisation. Medical history included hypothyroidism and glaucoma, known allergies: Sulfa. Concomitant medication(s) included levothyroxine 0.088mcg; latanoprost 125 mcg and vitamin taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, at 07:30 the patient experienced nosebleeds. Began 25Mar2021 and has had 11 episodes since then. Mostly from the left side, last 20 min to 65 min. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received no treatment for the event. The outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.
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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)) | 1 | COVID19 | PFIZER\BIONTECH | EN6208 | LA |
| RECVDATE: | 11-18-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | LEVOTHYROXINE; LATANOPROST |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Glaucoma; Hypothyroidism; Sulfonamide allergy |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2021495071 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-17-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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