Sex: F
Vaccine: COVID19
Symptoms: Hyperkeratosis, Microscopy
Clinical narrative: This is a literature report for the following literature source(s): "COVID-19 mRNA vaccine BNT162b2 induces autoantibodies against type I interferons in a healthy woman", Journal of Autoimmunity. A 50-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose), administration date: 06Jan2021, for Covid-19 immunization. The following information was reported: HYPERKERATOSIS (medically significant) with onset Feb2021, outcome "recovered", described as "dermatitis by the left inferior lateral shin excoriated indurated hyperkeratotic plaques for about six months following the second dose of vaccine"; DERMATITIS (medically significant) with onset Feb2021, outcome "recovered", described as "severe dermatitis". The patient underwent the following laboratory tests and procedures: Antibody test: (unspecified date) increased plasma levels of IgGs, notes: against SARS-CoV-2 S, S1, and SARS-Cov-2 S1RBD post-vaccination compared to baseline; Biopsy: (04Oct2021) Diagnosed with dermatitis, notes: lichen simplex chronicus. Gross description: Punch biopsy measuring 4x4x3 mm. The specimen is bisected and submitted in one cassette; Blood immunoglobulin G: (unspecified date) Similar plasma levels of IgG and IgM, notes: autoantibodies were observed in the three visits, including autoantigens associated with autoimmune diseases, inflammation/stress, and cell-associated molecules; (unspecified date) Unexpectedly, we found that plasma levels of IgG, notes: autoantibodies against type I interferons (IFNs), including IFN-alpha 4B, IFN-alpha A, IFN-alpha B2, IFN-alpha C, IFN-alpha D, IFN-alpha F, IFN-alpha G, IFN-alpha H2, IFN-alpha I, IFN-alpha J1, IFN-alpha K, IFN-alpha WA, IFN-beta, IFN-beta1 IFN-little-omega, were increased post-compared to pre-vaccination; (unspecified date) IgG of IFN- Epsilon, IFN-gamma increased in visit, notes: 2 compared to visit 1 but decreased in visit 3; (unspecified date) IgG against IFN-type III, IFN- lambda and levels, notes: of IgM did not differ in the three visits; Blood immunoglobulin M: (unspecified date) Similar plasma levels of IgG and IgM, notes: autoantibodies were observed in the three visits, including autoantigens associated with autoimmune diseases, inflammation/stress, and cell-associated molecules; (unspecified date) levels of IgM did not differ, notes: in the three visits; Microscopy: (unspecified date) The epidermis exhibits irregular psoriasis form, notes: hyperplasia with hyper granulosis and marked compact hyperkeratosis. The papillary dermis is fibrotic and thickened with collagen in vertical streaks. Therapeutic measures were taken as a result of dermatitis, hyperkeratosis. No follow-up attempts are needed. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events dermatitis, hyperkeratosis. Cannot be excluded. 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.