discolouration; dvt; this case was received via ra (reference number: gb-mhra-adr 26652926) on 27-feb-2022 and was forwarded to moderna on 27-feb-2022. this regulatory authority case was reported by a consumer and describes the occurrence of skin discolouration (discolouration) and deep vein thrombosis (dvt) in a 20-year-old female patient who received mrna-1273 (moderna covid-19 vaccine) for an unknown indication. concomitant products included tozinameran (covid-19 mrna vaccine bnt162b2) from 22-jan-2021 to an unknown date and tozinameran (covid-19 mrna vaccine bnt162b2) for vaccination. on 29-dec-2021, the patient received third dose of mrna-1273 (moderna covid-19 vaccine) (unknown route) 1 dosage form. on 12-feb-2022, the patient experienced deep vein thrombosis (dvt) (seriousness criteria hospitalization, medically significant and life threatening). on an unknown date, the patient experienced skin discolouration (discolouration) (seriousness criteria hospitalization, medically significant and life threatening). at the time of the report, skin discolouration (discolouration) was resolving and deep vein thrombosis (dvt) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 24-oct-2021, sars-cov-2 test: positive (positive) positive yes - positive covid-19 test. the action taken with mrna-1273 (moderna covid-19 vaccine) (unknown) was unknown. company comment: this regulatory case concerns a 20-year-old, female patient with history of covid-19 (sars-cov-2 test: positive) as on 24-oct-2021, who experienced the unexpected serious life threatening aesi of deep vein thrombosis and unexpected serious life-threatening event of skin discolouration (seriousness criteria hospitalization and medically significant). the event skin discolouration occurred on an unknown date and deep vein thrombosis occurred 45 days after the third dose of mrna-1273 vaccine. patient had upper limb dvt to left arm, pagets schrotter syndrome in subclavian vein. patient had long term weakened and discolouration due to lack of perfusion and adequate oxygenation to left arm. blood clot was unable to be thrombolysed and left on blood thinners whilst ongoing investigations, blood clot remained in subclavian vein. the patient was noted to have received two doses from tozinameran 8 months 14 days prior to current vaccination with mrna1273 (interchange of vaccine products). patients history of covid-19 (sars-cov-2 test: positive) remains confounder for deep vein thrombosis. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority�s report.; sender's comments: this regulatory case concerns a 20-year-old, female patient with history of covid-19 (sars-cov-2 test: positive) as on 24-oct-2021, who experienced the unexpected serious life threatening aesi of deep vein thrombosis and unexpected serious life-threatening event of skin discolouration (seriousness criteria hospitalization and medically significant). the event skin discolouration occurred on an unknown date and deep vein thrombosis occurred 45 days after the third dose of mrna-1273 vaccine. patient had upper limb dvt to left arm, pagets schrotter syndrome in subclavian vein. patient had long term weakened and discolouration due to lack of perfusion and adequate oxygenation to left arm. blood clot was unable to be thrombolysed and left on blood thinners whilst ongoing investigations, blood clot remained in subclavian vein. the patient was noted to have received two doses from tozinameran 8 months 14 days prior to current vaccination with mrna1273 (interchange of vaccine products). patients history of covid-19 (sars-cov-2 test: positive) remains confounder for deep vein thrombosis. the benefit-risk relationship of mrna-1273 vaccine is not affected by this report. the case was assessed as serious as per regulatory authority�s report

test date: 20211024; test name: covid-19 virus test; test result: positive ; result unstructured data: positive yes - positive covid-19 test

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