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.
completely impotent/unable to achieve an erection; no feeling in penis; unable to achieve orgasm; This is a spontaneous report received from a contactable consumer (patient). This 54-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0175) at single dose on 29Apr2021 10:00 AM via an unknown route in left arm at 54-year-old for Covid-19 immunization. Medical history included diabetes, hypogonadism, slight hypertension. Patient had no known allergies. There was no any other medications the patient received within 2 weeks of vaccination. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew0150) on 08Apr2021 10:00 AM in left arm at 54-year-old for Covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient become completely impotent. He had no feeling in private area. He was unable to achieve orgasm. Even taking Ed medication he was unable to achieve an erection. The event onset date was 01May2021 at 12:00 PM. The event resulted in Doctor or other healthcare professional office/clinic visit due to disability or permanent damage. No other treatment received for the adverse event. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: nasal Swab PCR on 21Jul2021 and 23Jul2021, both were negative. Outcome of the events was not resolved. The event was reported as serious with disabling/Incapacitating.
Open in Wayback Machine
(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.)
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||Ew0175||Unknown||LA|
|LAB_DATA:||Test Date: 20210721; Test Name: Covid-19 test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210723; Test Name: Covid-19 test; Test Result: Negative ; Comments: Nasal Swab|
|HISTORY:||Medical History/Concurrent Conditions: Diabetes (Other medical history: Diabetes); Hypertension (Other medical history: slight hypertension); Hypogonadism (Other medical history: hypogonadism)|
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