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. 2023 Jan;32(1):106860.
doi: 10.1016/j.jstrokecerebrovasdis.2022.106860. Epub 2022 Nov 17.

Vaccine associated benign headache and cutaneous hemorrhage after ChAdOx1 nCoV-19 vaccine: A cohort study

Nina Haagenrud Schultz  1 , Arne Vasli Lund Søraas  2 , Ingvild Hausberg Sørvoll  3 , Çigdem Akalin Akkök  4 , Annette Vetlesen  4 , Jagjit Singh Bhamra  4 , Maria Therese Ahlen  3 , Pål Andre Holme  5 , Anne-Hege Aamodt  6 , Karolina Skagen  6 , Thor Håkon Skattør  7 , Mona Skjelland  8 , Markus Kh Wiedmann  9
Affiliations

Vaccine associated benign headache and cutaneous hemorrhage after ChAdOx1 nCoV-19 vaccine: A cohort study

Nina Haagenrud Schultz et al. J Stroke Cerebrovasc Dis. 2023 Jan.

Abstract

Objectives: Fatal complications have occurred after vaccination with ChAdOx1 nCoV-19, a vaccine against Covid-19. Vaccine-induced immune thrombotic thrombocytopenia (VITT) with severe outcome is characterized by venous thrombosis, predominantly in cerebral veins, thrombocytopenia and anti-PF4/polyanion antibodies. Prolonged headaches and cutaneous hemorrhages, frequently observed after the ChAdOx1 nCoV-19 vaccine, have therefore caused anxiety among vaccinees. We investigated whether these symptoms represent a mild form of VITT, with a potential for aggravation, e.g. in case of a second vaccination dose, or a different entity of vaccine complications MATERIALS AND METHODS: We included previously healthy individuals who had a combination of headache and spontaneous severe cutaneous hemorrhages emerging after the 1st dose of the ChAdOx1 nCoV-19 vaccine. Twelve individuals were found to meet the inclusion criteria, and a phone interview, cerebral MRI, assessment of platelet counts, anti PF4/polyanion antibodies and other laboratory tests were performed.

Results: None of the symptomatic vaccinees had cerebral vein thrombosis, hemorrhage or other pathology on MRI. Platelet counts were within normal range and no anti-PF4/polyanion platelet activating antibodies were found. Moreover, vasculitis markers, platelet activation markers and thrombin generation were normal. Furthermore, almost all symptoms resolved, and none had recurrence of symptoms after further vaccination with mRNA vaccines against Covid-19.

Conclusions: The combination of headaches and subcutaneous hemorrhage did not represent VITT and no other specific coagulation disorder or intracranial pathology was found. However, symptoms initially mimicking VITT demand vigilance and low threshold for a clinical evaluation combined with platelet counts and D-dimer.

Keywords: Adverse event; ChAdOx1 nCoV vaccine; Cutaneous hemorrhage; Headache.

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Conflict of interest statement

Declaration of Competing Interest N.H.S. has received honoraria from Pfizer, BMS, and Bayer for lectures about management of anticoagulation treatment and bleeding. P.A.H. has received research grants to institution from Bayer, Pfizer, SOBI, and Roche within area of bleeding disorders, and lecture honoraria, and honoraria for participation in advisory boards in the area of bleeding disorders from Takeda, SOBI, Bayer, Pfizer, Roche, Octapharma, NovoNordisk, CSL and BMS. He has received support for attending meetings from Takeda, Bayer, Roche, Pfizer, Octapharma, NovoNordisk, CSL and SOBI, and he is a member of executive committee of the ADVANCE group and ACHIEVE group, Bayer. I.H.S. reports that her spouse is the CEO in ArcticZymes Technologies. A.A. has received personal fees from Bayer, Boehringer Ingelheim, Roche, Allergan, Novartis and Teva. K.S. has received personal fees from Bayer. M.K.H.W. has received research grants from the South-Eastern Norway Regional Health Authority, and reports ownership of stock Biontech/Pfizer. A.V.L.S., C.A., A.V., J.S.B., M.T.A., T.H.S. and M.S. have no conflicting interests.

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