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.
light headedness; shortness of breath; headache; some nausea; get some redness to her neck and upper chest; Had elevated BPs; This is a spontaneous report from a contactable pharmacist. A 41-year-old female patient (non-pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number: EH9899), intramuscularly on right arm on 15Dec2020 at 13:30 at single dose for immunization. The COVID-19 vaccine was administered in hospital. Medical history included arrhythmia - right bundle branch block, GERD (Gastrooesophageal reflux disease), spinal headache, allergy to gabapentin, adhesive, duloxetine hydrochloride (CYMBALTA). The patient wears contact lenses. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN, 5-325 mg), omeprazole, meloxicam, docusate sodium, sennoside a+b (SENNA AND DOCUSATE SODIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within a few minutes of receiving the shot on 15Dec2020, the patient developed lightheadedness, shortness of breath, headache, and some nausea and was taken to the ED (emergency department). She did get some redness to her neck and upper chest, had elevated blood pressure. O2 saturation was fine. The patient received treatment for the events which included acetaminophen (TYLENOL), dexamethasone, diphenhydramine, famotidine, ketorolac, ondansetron, and 1 L normal saline in ED. The patient was prescribed adrenalin autoinjector (EPIPEN) and prednisone and discharged home. Since the vaccination, the patient hadn't been tested for COVID-19. Outcome of reactions was resolved in Dec2020.; Sender's Comments: Based on the close temporal relationship and the description of the events lightheadedness, shortness of breath, headache, nausea, erythema and high blood pressure, there is a reasonable possibility that the events are related to BNT162b2 vaccine. The case will be reassessed upon receipt of follow up information.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EH9899 | OT | RA |
| RECVDATE: | 12-22-2020 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 20201215; Test Name: BPs; Result Unstructured Data: Test Result:elevated; Test Date: 20201215; Test Name: O2 sats; Result Unstructured Data: Test Result:fine |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | HYDROCODONE/ACETAMINOPHEN; ; ; SENNA AND DOCUSATE SODIUM |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Adhesive tape allergy; Arrhythmia (Arrhythmia - right bundle branch block); Bundle branch block right (Arrhythmia - right bundle branch block); Contact lens wearer; GERD; Headache (Spinal headache) |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2020496580 |
| FORM_VERS: | |
| TODAYS_DATE: | 12-19-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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