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.
Alopecia areata; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-PS20220756. A 66-year-old female patient received BNT162b2 (COMIRNATY), on 19Apr2021 as dose 2, 30 ug, single (Lot number: EW2246) intramuscular, in left arm for covid-19 immunisation; enalapril (ENALAPRIL), (ongoing) at 20 mg 1x/day, oral for hypertension; amlodipine (AMLODIPINE), at 10 mg 1x/day, oral for hypertension; rituximab (RITUXIMAB), since 19Nov2018 (Batch/Lot number: unknown), intravenous for multiple sclerosis. The patient's relevant medical history included: "Sclerosis multiple" (unspecified if ongoing), notes: Relapsing remitting followed by secondary-progressive multiple sclerosis with additional surges; "shingles" (unspecified if ongoing), notes: In the right side of the body; "asthma" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "surgical management of a spinal cord meningioma" (unspecified if ongoing); "bilateral knee replacement" (unspecified if ongoing); "bilateral cataract surgery" (unspecified if ongoing); "appendectomy" (unspecified if ongoing). Concomitant medication(s) included: FAMPYRA; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; VITAMIN D NOS; DITROPAN; ZOPICLONE. Vaccination history included: comirnaty (DOSE 1, SINGLE, Batch: EP9605, Left arm), administration date: 22Mar2021, for COVID-19 immunization. The following information was reported: ALOPECIA AREATA (hospitalization, medically significant) with onset May2021, outcome "unknown". The patient was hospitalized for alopecia areata (start date: 28Mar2022, discharge date: 30Mar2022, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (Jul2019) stability of brain and spinal cord lesions, notes: without contrast enhancement. The action taken for enalapril, amlodipine and rituximab was dosage not changed. Therapeutic measures were taken as a result of alopecia areata. Clinical course: On 17May2021: letter for the dermatologist "the patient presented with alopecia \ for several months, bilaterally, progressively worsening over a period of several months. There did not appear to be other associated dermatological symptoms. Rituximab seems to be one of the causes of alopecia, but we would like to see those other differential diagnoses and adapted medical care were eliminated. On 29Nov2021: booster injection of Comirnaty 1G047A left arm. On 23Mar2022: indication for corticosteroid bolus medical care for alopecia areata (Dermatologist's opinion). From 28 to 30Mar2022: Day hospital for methylprednisolone 500mg bolus for 3 days. On May2022: next course of rituximab. Discussion/conclusion of their analysis: In summary, the role of these medications (rituximab, Comirnaty, enalapril and amlodipine) cannot be excluded, the available data do not allow us to suspect rituximab more than the Comirnaty vaccine.
| Vaccine Type | Manufacturer | Vaccine Name | Dose | Route | Site | Lot |
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| RECVDATE: | 11 May 2022 |
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| RPT_DATE: | |
| DIED: | |
| DATEDIED: | |
| L_THREAT: | |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | |
| DISABLE: | |
| RECOVD: | U |
| LAB_DATA: | Test Date: 201907; Test Name: Cerebral and medullar Magnetic Resonance Imaging; Result Unstructured Data: Test Result:stability of brain and spinal cord lesions; Comments: without contrast enhancement |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | FAMPYRA; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DITROPAN; ZOPICLONE |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Appendectomy; Asthma; Cataract operation; Hypertension; Knee replacement; Meningioma surgery; Sclerosis multiple (Relapsing remitting followed by secondary-progressive multiple sclerosis with additional surges); Shingles (In the right side of the body) |
| PRIOR_VAX: | |
| SPLTTYPE: | FRPFIZER INC202200656766 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 10 May 2022 |
| BIRTH_DEFECT: | |
| OFC_VISIT: | |
| ER_ED_VISIT: | |
| ALLERGIES: | |
| V_FUNDBY: | |
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