Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Peroneal nerve palsy, Platelet count, Platelet count decreased, Systemic mycosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (pericarditis), HAEMORRHAGE (bleeding issues), SYSTEMIC MYCOSIS (rare fungus on right hand, around finger, fungus got into blood, systemic fungus infection) and ATRIAL FIBRILLATION (Atrial fibrillation) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 029L20A and 092L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Neutropenia (hospitalized for neutropenia in 2018). Previously administered products included for Product used for unknown indication: Amoxicillin. Past adverse reactions to the above products included Drug allergy with Amoxicillin. Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), CLL (Started in 2008 or 2010. No change reported (under control)), Solid tumor (Started in 2008 or 2010. Recent change in status such as improvement or worsening: Unknown), Anal cancer metastatic (Recent change in status such as improvement or worsening: Unknown) since 2020, Immunocompromised and Squamous cell carcinoma of liver (Recent change in status such as improvement or worsening: Unknown) since 2020. Concomitant products included INFLUENZA VACCINE for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. In October 2021, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant), SYSTEMIC MYCOSIS (rare fungus on right hand, around finger, fungus got into blood, systemic fungus infection) (seriousness criterion medically significant), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and PERONEAL NERVE PALSY (foot drop). On an unknown date, the patient experienced HAEMORRHAGE (bleeding issues) (seriousness criterion medically significant), CONTUSION (bruises), PLATELET COUNT DECREASED (low platelets) and MUSCLE ATROPHY (lost a lot of muscle). The patient was hospitalized for 5 days due to PERICARDITIS. The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency; Surgery (Hand surgery) for Systemic mycosis and Surgery (Cardioversion) for Atrial fibrillation. On 25-Feb-2022, ATRIAL FIBRILLATION (Atrial fibrillation) had resolved. At the time of the report, PERICARDITIS (pericarditis), HAEMORRHAGE (bleeding issues), SYSTEMIC MYCOSIS (rare fungus on right hand, around finger, fungus got into blood, systemic fungus infection), PERONEAL NERVE PALSY (foot drop), CONTUSION (bruises), PLATELET COUNT DECREASED (low platelets) and MUSCLE ATROPHY (lost a lot of muscle) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: low Low. Treatment included: Anti-fungal medication, cardioversion, surgery for hand and finger fungus. The patient experienced pericarditis also gave him atrial fibrillation and he had cardioversion and was placed on blood thinners. She stated the cardioversion (performed on 25 Feb 2022) placed heart back into normal rhythm. The patient had no reaction to first or second Moderna doses. The patient not had history of pericarditis. The patient was diagnosed with a rare fungus on right hand and around finger and had to have hand surgery. She stated the fungus also got into his blood and he was diagnosed with systemic fungus infection. He was placed on an antifungal medication (unknown medication name). The patient had low platelets from the oral CLL treatment. The patient heart was back to normal now. The patient never had COVID + test or diagnosis. Company Comment: This spontaneous case concerns an 80-year-old male patient, with relevant medical history of CLL, Solid tumor, Anal cancer metastatic, Immunocompromised and Squamous cell carcinoma of liver, who experienced the expected serious AESI of Pericarditis, the unexpected AESI of Atrial fibrillation, the unexpected events of Systemic mycosis, Peroneal nerve palsy, Hemorrhage, Contusion, Platelet count decreased and Muscle atrophy. The events occurred approximately 2 months after receiving the third dose of mRNA-1273 Vaccine. The patient was hospitalized for 5 days due to Pericarditis and was treated with Apixaban, had hand surgery for Systemic mycosis and Cardioversion for Atrial fibrillation. The outcome of the events was unknown except for Atrial fibrillation which was resolved. The patient's medical history of CLL, Solid tumor, Anal cancer metastatic, Immunocompromised and Squamous cell carcinoma of liver remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns an 80-year-old male patient, with relevant medical history of CLL, Solid tumor, Anal cancer metastatic, Immunocompromised and Squamous cell carcinoma of liver, who experienced the expected serious AESI of Pericarditis, the unexpected AESI of Atrial fibrillation, the unexpected events of Systemic mycosis, Peroneal nerve palsy, Hemorrhage, Contusion, Platelet count decreased and Muscle atrophy. The events occurred approximately 2 months after receiving the third dose of mRNA-1273 Vaccine. The patient was hospitalized for 5 days due to Pericarditis and was treated with Apixaban, had hand surgery for Systemic mycosis and Cardioversion for Atrial fibrillation. The outcome of the events was unknown except for Atrial fibrillation which was resolved. The patient's medical history of CLL, Solid tumor, Anal cancer metastatic, Immunocompromised and Squamous cell carcinoma of liver remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.