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.
respiratory distress; dyspnea; itching/ pruritus; edema; This is a spontaneous report from a non-contactable other healthcare professional. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ3002 and expiry date: 01Apr2021) intramuscular on the left arm on13Jan2021 16:13 at a SINGLE DOSE for COVID-19 immunisation. The patient's medical history included allergy (NOS) from an unknown date and unknown if ongoing; Covid-19 disease from 16Nov2020 to an unknown date; and subsequent stage cardiac arrhythmia as a complication of COVID-19 from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 13Jan2021, 16:20; 7 minutes after vaccination, the patient experienced respiratory distress. It was reported that the patient presented with frank dyspnea, itching, and edema. Patient was transferred to a hospital room for stabilization; proceeded with application of intramuscular adrenaline and cardiac monitorization procedure, It was reported that patient maintained a permeable venous access. A reservoir mask was placed at 10 liters/min. Later the patient showed improvement, denied dyspnea, and pruritus. Examination of cardiac monitorization on 13Jan2021 showed neurologically integrated normohydrated, cardiorespiratory with arrhythmic precordium without murmurs, pulmonary field with good air inlet and outlet, without aggregates, without use of accessory muscles of respiration, normal rest, without dermal lesions, and immediate capillary filling. The patient received treatment for all the events. This case report was assessed as serious since the events involved hospital admission from 13Jan2021 to an unknown date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events respiratory distress, dyspnea, pruritus and oedema cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EJ3002 | OT | LA |
| RECVDATE: | 02-04-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | Test Date: 20210113; Test Name: cardiac monitorization; Result Unstructured Data: Test Result:neurologically integrated normohydrated; Comments: neurologically integrated normohydrated, cardiorespiratory with arrhythmic precordium without murmurs, pulmonary field with good air inlet and outlet, without aggregates, without use of accessory muscles of respiration, normal rest, without dermal lesions, immediate capillary filling. |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Allergy NOS; Cardiac arrhythmia (as a complication of COVID-19.); COVID-19 |
| PRIOR_VAX: | |
| SPLTTYPE: | MXPFIZER INC2021101426 |
| FORM_VERS: | |
| TODAYS_DATE: | 02-03-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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