Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Protein S, Prothrombin time, Pulmonary embolism, Respiratory failure, Skin necrosis
Clinical narrative: acute hypoxic hypercapnic respiratory failure; heparin-induced skin necrosis; right upper lobe lobar pulmonary embolism; hematuria; Multiple ecchymotic lesions on right forearm; This literature-non-study case was reported in a literature article and describes the occurrence of RESPIRATORY FAILURE (acute hypoxic hypercapnic respiratory failure), SKIN NECROSIS (heparin-induced skin necrosis), PULMONARY EMBOLISM (right upper lobe lobar pulmonary embolism) and HAEMATURIA (hematuria) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      The patient's past medical history included Percutaneous endoscopic gastrostomy (This was complicated by dysphagia status post percutaneous endoscopic gastrostomy tube placement) and Cardioversion (status post cardioversion). Concurrent medical conditions included Squamous cell carcinoma (treated with 6 cycles of chemoimmunotherapy and radiation and 8 months of pembrolizumab therapy.), Chronic obstructive pulmonary disease and Atrial fibrillation. Concomitant products included PEMBROLIZUMAB for Squamous cell carcinoma.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY FAILURE (acute hypoxic hypercapnic respiratory failure) (seriousness criteria hospitalization and life threatening), SKIN NECROSIS (heparin-induced skin necrosis) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (right upper lobe lobar pulmonary embolism) (seriousness criterion hospitalization), HAEMATURIA (hematuria) (seriousness criterion hospitalization) and INJECTION SITE HAEMORRHAGE (Multiple ecchymotic lesions on right forearm). The patient was treated with UNFRACTIONATED HEPARIN for Pulmonary embolism, at an unspecified dose and frequency; BIVALIRUDIN for Skin necrosis, at an unspecified dose and frequency; FONDAPARINUX for Skin necrosis, at a dose of 7.5 milligram once a day and Surgery (continuous bladder irrigation) for Haematuria. At the time of the report, RESPIRATORY FAILURE (acute hypoxic hypercapnic respiratory failure), PULMONARY EMBOLISM (right upper lobe lobar pulmonary embolism), HAEMATURIA (hematuria) and INJECTION SITE HAEMORRHAGE (Multiple ecchymotic lesions on right forearm) outcome was unknown and SKIN NECROSIS (heparin-induced skin necrosis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time: more than 200 s more than 200 s while on heparin. On an unknown date, Angiogram: abnormal (abnormal) demonstrated right upper lobe lobar pulmonary embolism with evidence of right heart strain.. On an unknown date, Blood fibrinogen: 499 mg/dl 499 mg/dl. On an unknown date, Blood immunoglobulin G: 1.45 od 1.45 OD and 2.15 od 2.15 OD. On an unknown date, Heparin-induced thrombocytopenia test: 6 6 and negative (Negative) Negative. On an unknown date, Immunology test: positive (Positive) Positive. On an unknown date, Platelet count: 309000/ul 309000/ul, 227000/ul 227000/ul and 366000/ul 366000/ul. On an unknown date, Protein C: 148 percent 148 percent. On an unknown date, Protein S: 8 percent 8 percent. On an unknown date, Prothrombin time: 17 s 17 s.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RESPIRATORY FAILURE (acute hypoxic hypercapnic respiratory failure), SKIN NECROSIS (heparin-induced skin necrosis), PULMONARY EMBOLISM (right upper lobe lobar pulmonary embolism), HAEMATURIA (hematuria) and INJECTION SITE HAEMORRHAGE (Multiple ecchymotic lesions on right forearm) to be related.    Patient received the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 vaccine 5 weeks prior to presentation. Company comment:This is a literature case that concerns a 76-year-old male patient with concurrent medical condition of  Squamous cell carcinoma (treated with six cycles of chemoimmunotherapy and radiation followed by 8 months of pembrolizumab maintenance therapy), Chronic obstructive pulmonary disease and Atrial fibrillation, who experienced the unexpected serious events of  Respiratory failure (seriousness criteria life threatening  and hospitalization), Skin necrosis (AESI) (seriousness criteria medically significant and hospitalization), Pulmonary embolism and Hematuria (seriousness criteria hospitalization)  which occurred 5 weeks after receiving the first dose of mRNA-1273 Vaccine.  He was admitted for unresponsiveness and was intubated for acute hypoxic hypercapnic respiratory failure. CT angiography demonstrated right upper lobe lobar pulmonary embolism with evidence of right heart strain. The patient was started on continuous therapeutic unfractionated heparin (UFH) infusion. He developed multiple ecchymotic lesions on right forearm near the heparin infusion intravenous site within 3 days of heparin initiation. the patient's 4T score of 6, heparin was held, and a HIT Ab panel was sent. The patient's platelet count dropped from 309000/ml to 227000/ml. Thrombophilia evaluation included an international normalized ratio of 1.5, a prothrombin time of 17 s, partial thromboplastin time of more than 200 s while on heparin. Duplex venous and arterial ultrasounds were unremarkable. The recurrent pulmonary infections and an inability to continue with cancer treatment.Patient's concurrent medical condition remains as a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2022: Follow up was received by safety on 16-Feb-2022 has Email with FTA received from team with significant information. Lab data, events, treatment and concomitant medications were added.; Sender's Comments: This is a literature case that concerns a 76-year-old male patient with concurrent medical condition of  Squamous cell carcinoma (treated with six cycles of chemoimmunotherapy and radiation followed by 8 months of pembrolizumab maintenance therapy.), Chronic obstructive pulmonary disease and Atrial fibrillation , who experienced the unexpected serious events of  Respiratory failure (seriousness criteria life threatening  and hospitalization),Skin necrosis (AESI) (seriousness criteria medically significant and hospitalization),  Pulmonary embolism and  Hematuria (seriousness criteria hospitalization)  which occurred 5 weeks after receiving the first dose of mRNA-1273 Vaccine.  He was admitted for unresponsiveness and was intubated for acute hypoxic hypercapnic respiratory failure. CT angiography demonstrated right upper lobe lobar pulmonary embolism with evidence of right heart strain. The patient was started on continuous therapeutic unfractionated heparin (UFH) infusion. He developed multiple ecchymotic lesions on right forearm near the heparin infusion intravenous site within 3 days of heparin initiation. the patient's 4T score of6, heparin was held, and a HIT Ab panel was sent. The patient's platelet count dropped from 309 000/ml to 227 000/ml. Thrombophilia evaluation included an international normalized ratio of 1.5, a prothrombin time of 17 s, partial thromboplastin time of more than 200 s while on heparin. Duplex venous and arterial ultrasounds were unremarkable. The recurrent pulmonary infections and an inability to continue with cancer treatment.Patient's concurrent medical condition remains as a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.