Case Report: Acquired Haemophilia A Following mRNA-1273 Booster Vaccination Against SARS-CoV-2 With Concurrent Diagnosis of Pleomorphic Dermal Sarcoma

Abstract

While the global pandemic caused by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is still ongoing and new virus variants are emerging, there is a universal need for vaccines to protect individuals from severe complications and ideally control the pandemic by enabling herd immunity. Several vaccines against SARS-CoV-2 have been approved and are widely used to stem the recurring waves of coronavirus disease 2019 (COVID-19). Post-marketing surveillance is essential to record even rare safety issues related to these new vaccines. Among these issues, several autoimmune phenomena have been recorded in temporal association with and feasibly triggered by a vaccination. Acquired haemophilia A (AHA) is a rare condition characterized by new-onset haemorrhagic diathesis caused by an inhibitor of blood clotting factor VIII (FVIII), often in the elderly and most commonly associated with autoimmune or malignant disease. There have been a small number of AHA cases triggered by vaccinations, including those against SARS-CoV-2. We report the first case of AHA in temporal association with an mRNA-1273 booster vaccination. The diagnosis was made promptly, and the patient received appropriate care including immunosuppression using glucocorticoids, cyclophosphamide (CYC) and rituximab (RTX). The haemorrhage ceased after escalation of treatment, and the patient is recovering. Concurrent malignancy was initially ruled out using a wide scope of diagnostic tests, but pleomorphic dermal sarcoma (PDS) of the forehead occurred after initiation of specific AHA immunosuppressive treatment. Since large vaccination programs are ongoing worldwide and potential adverse events during post-marketing surveillance have been reported following vaccination against SARS-CoV-2, this case illustrates challenges in rare events occurring in association with SARS-CoV-2 vaccination and to proof a causal relationship. Therefore, there is an urgent need for reporting any events in association with SARS-CoV-2 vaccination, but also a crucial discussion about possible concurrent triggers and follow-up information about individual patients.

Cases of acquired hemophilia A following COVID‐19 vaccines: Cogent safety signal or possible reporting/detection bias? Preliminary evidence from Tuscany, Italy

“…3 During the COVID-19 immunization campaign different case reports of AHA diagnosed following COVID-19 vaccination, mainly with mRNA vaccines, were described in the published literature. 1,[7][8][9][10] The possibility of higher-than-expected AHA incidence during the COVID-19 immunization was also suggested in one Italian province. 7 Although, AHA cases have been observed also following SARS-CoV-2 infections and influenza vaccinations, 11,12 in Italy, COVID-19 coverage was particularly high, with 82% of the population having received at least the first dose at the end of 2021 (76% with complete primary vaccination serie), with mRNA vaccines from Pfizer and Moderna corresponding to the 68% and 20% of the overall vaccine doses administered, respectively.…”

“…During the COVID‐19 immunization campaign different case reports of AHA diagnosed following COVID‐19 vaccination, mainly with mRNA vaccines, were described in the published literature 1,7–10 . The possibility of higher‐than‐expected AHA incidence during the COVID‐19 immunization was also suggested in one Italian province 7 .…”

COVID-19 vaccine adverse events: Evaluating the pathophysiology from an undersulfated and degraded glycocalyx perspective

“…There has been an increase in breast and lung cancer cases reported to VAERS, while pancreatic, ovarian, and bladder cancers were directly linked to the COVID-19 vaccines 56 . One could also expect more cancers related to sarcoma, leukemia, and lymphoma after COVID-19 vaccination [314][315][316][317][318][319][320][321][322] . It is still unclear whether the increase in lymphadenopathy diagnosed post-COVID-19 vaccination is due to an immune response to the vaccine or an underlying malignant process.…”

Hemmkörperhämophilie: aktuelle Aspekte

“…In letzter Zeit häufen sich Fallberichte von Hemmkörperhämophilien in Zusammenhang mit COVID oder Impfungen gegen SARS-CoV2 6 7 .…”