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.
Very Bad Nose Bleeds; Elevated BP/my BP spiked to 140/98; Elevated heart rate/ my heartrate accelerated to over 100 bpm; Throat Tightened; Chest tightened; Difficult to breath; Severe Headache; Mild Pain/ Mild body aches; Anaphylaxis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient received BNT162b2 (COMIRNATY), on 22Mar2022 at 10:30 as dose 2, single (Lot number: PCA0033) at the age of 55 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Anaphylaxis"; CHEST DISCOMFORT (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Chest tightened"; DYSPNOEA (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Difficult to breath"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Elevated BP/my BP spiked to 140/98"; HEART RATE INCREASED (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Elevated heart rate/ my heartrate accelerated to over 100 bpm"; PAIN (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Mild Pain/ Mild body aches"; HEADACHE (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Severe Headache"; THROAT TIGHTNESS (non-serious) with onset 22Mar2022 at 12:30, outcome "recovering", described as "Throat Tightened"; EPISTAXIS (medically significant) with onset 24Mar2022, outcome "recovering", described as "Very Bad Nose Bleeds". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (22Mar2022) 140/98, notes: (no units given); Heart rate: (22Mar2022) 100 bpm, notes: over 100 bpm. Therapeutic measures were taken as a result of epistaxis. No follow-up attempts are possible. No further information is expected. Follow-up (03May2022): This is a follow-up spontaneous report received from the contactable reporter(s) (Consumer or other non HCP). Updated information: Concomitant medication, Outcomes of the events were updated as "recovering/resolving". Treatment for nose bleeding included nose cauterization and was upgraded to medically significant. The patient was not hospitalized. The patient did not have a history of any previous allergies to specific products or any conditions indicative of an allergy. No follow-up attempts are possible. No further information is expected.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | PCA0033 |
| RECVDATE: | 05-06-2022 | 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: | Test Date: 20220322; Test Name: BP; Result Unstructured Data: Test Result:140/98; Comments: (no units given); Test Date: 20220322; Test Name: Heartrate; Result Unstructured Data: Test Result:100 bpm; Comments: over 100 bpm |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | FLU VACCINE VII |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
| PRIOR_VAX: | |
| SPLTTYPE: | ZAPFIZER INC202200593863 |
| FORM_VERS: | |
| TODAYS_DATE: | 05-05-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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