Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Cardiac disorder, Cardiomegaly, Feeling abnormal
Clinical narrative: Heart did not closed correctly; Enlarged heart; Stamina being down/problem with stamina/energy drained is more; Spots of psoriasis on legs; Fog headed; Asthma flared up; Vaccine dose 1 received on 01-Oct-2020 and dose 2 received on 01-Jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart did not closed correctly), CARDIOMEGALY (Enlarged heart) and ASTHENIA (Stamina being down/problem with stamina/energy drained is more) in a 62-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis and Asthma.   In 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 01-Oct-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine dose 1 received on 01-Oct-2020 and dose 2 received on 01-Jan-2021). On an unknown date, the patient experienced CARDIAC DISORDER (Heart did not closed correctly) (seriousness criterion hospitalization), CARDIOMEGALY (Enlarged heart) (seriousness criterion hospitalization), ASTHENIA (Stamina being down/problem with stamina/energy drained is more) (seriousness criterion hospitalization), PSORIASIS (Spots of psoriasis on legs), FEELING ABNORMAL (Fog headed) and ASTHMA (Asthma flared up). At the time of the report, CARDIAC DISORDER (Heart did not closed correctly) and ASTHENIA (Stamina being down/problem with stamina/energy drained is more) had not resolved, CARDIOMEGALY (Enlarged heart), PSORIASIS (Spots of psoriasis on legs), FEELING ABNORMAL (Fog headed) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine dose 1 received on 01-Oct-2020 and dose 2 received on 01-Jan-2021) outcome was unknown and ASTHMA (Asthma flared up) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Company comment : This spontaneous case concerns a 62-year-old, male patient with medical history of Plaque Psoriasis treated with the co-suspect product Humira (adalimumab) and medical history of Asthma, who experienced the unexpected, serious (hospitalization) events of cardiac disorder, cardiomegaly and asthenia, and other unexpected, non-serious events. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. Moreover, it could not be assessed if the events occurred after the first dose or the second dose of the mRNA-1273 vaccine. Of note, the second dose was given 3 months after the first dose of the mRNA-1273 vaccine (inappropriate schedule of product administration). It was reported that the patient's heart condition (unspecified) started after taking Humira. He was on Humira for 3 years and stopped due to heart issues (unspecified). He had been off Humira for about 3 to 4 months at the time of the report. On an unspecified date, the patient visited the Emergency room and tried to get his heart checked. No details were provided regarding the consultation. On an unknown date, the patient was hospitalized and he was struggling with his stamina being down and his energy was drained. It was also reported that the patient had an enlarged heart. No further clinical information (including details about hospitalization, diagnostic test/s, clinical course and treatment) was available for medical review. It was reported that the doctors 'could not find enough problem with the patient to cut him open' and that there was 'not enough blockage'. It was also reported that the patient had spots of psoriasis on his legs, experienced foggy head, and his asthma had flared up which had not happened in years. The medical history of Plaque Psoriasis, an autoimmune condition characterized by flares and remission, remains a confounder for the event psoriasis. Of note, the patient discontinued Humira, therefore, this also remains a confounder for the event psoriasis. The medical history of Asthma, characterized by exacerbations, remains a confounder for the event asthma aggravated. The history of co-suspect administration of Humira remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   No concomitant medications were reported.   The patient reported that his heart condition started after taking Humira. He also asked question to the medical information regarding deep vein thrombosis and cellulitis but did not disclosed if he had those conditions. He was taking other unknown medications. He was on Humira for 3 years and stopped due to getting heart issues. He was hospitalized and he was struggling with his stamina being down. He did have spots of psoriasis on his legs but did not think he needed the Humira if it causes heart issues. Patient stated that he had been off Humira about 3 to 4 months. He was having difficulty with housing and etc. at this time. He was having a problem with stamina. His energy drained was more the description. He was wondering if the fog headed symptom from the Moderna COVID Vaccine. He did visit emergency room and he was trying to get his heart checked. He stated there was something tied to the Moderma COVID vaccine. His asthma had flared up and that had not happened in years. He also stated he had wondered if it had to do with the Moderna Covid Vaccine. He went to two emergency rooms and he got no help. They could not find enough problem with the patient to cut him open. There was not enough blockage. It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the event(s) of heart did not closed correctly, stamina being down/problem with stamina/energy drained is more, spots of psoriasis on legs, self discontinued Humira due to personal situations, fog headed, asthma flared up and difficulty with housing was not provided. the reporter's causality for the event(s) of enlarged heart with Humira(adalimumab) was a reasonable possibility.   No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 62-year-old, male patient with medical history of Plaque Psoriasis treated with the co-suspect product Humira (adalimumab) and medical history of Asthma, who experienced the unexpected, serious (hospitalization) events of cardiac disorder, cardiomegaly and asthenia, and other unexpected, non-serious events. The events occurred unknown number of days after receiving Humira and unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the event onset dates were not provided, hence, the onset latency could not be assessed. Moreover, it could not be assessed if the events occurred after the first dose or the second dose of the mRNA-1273 vaccine. Of note, the second dose was given 3 months after the first dose of the mRNA-1273 vaccine (inappropriate schedule of product administration). It was reported that the patient's heart condition (unspecified) started after taking Humira. He was on Humira for 3 years and stopped due to heart issues (unspecified). He had been off Humira for about 3 to 4 months at the time of the report. On an unspecified date, the patient visited the Emergency room and tried to get his heart checked. No details were provided regarding the consultation. On an unknown date, the patient was hospitalized and he was struggling with his stamina being down and his energy was drained. It was also reported that the patient had an enlarged heart. No further clinical information (including details about hospitalization, diagnostic test/s, clinical course and treatment) was available for medical review. It was reported that the doctors 'could not find enough problem with the patient to cut him open' and that there was 'not enough blockage'. It was also reported that the patient had spots of psoriasis on his legs, experienced foggy head, and his asthma had flared up which had not happened in years. The medical history of Plaque Psoriasis, an autoimmune condition characterized by flares and remission, remains a confounder for the event psoriasis. Of note, the patient discontinued Humira, therefore, this also remains a confounder for the event psoriasis. The medical history of Asthma, characterized by exacerbations, remains a confounder for the event asthma aggravated. The history of co-suspect administration of Humira remains a confounder for the reported events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.