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.
Extreme night sweats; Very sore and achy; Bad cough; Fatigue; Vomiting; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03May2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151), via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 17:00, the patient experienced very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events very sore and achy, bad cough, fatigue, vomiting, fever, headache and extreme night sweats were not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: treatment received was ticked/selected as no and following information was added in narrative: No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | Unknown | 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: | PHM |
OTHER_MEDS: | IBUPROFEN |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC2021502252 |
FORM_VERS: | |
TODAYS_DATE: | 11-17-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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