Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, Pneumonia, Pyrexia, Vaccination failure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia on left lung), DYSPNOEA (Difficulty breathing), CHEST PAIN (Recurrent chest pain), ARTHRALGIA (Arthritic pains), PYREXIA (Fever), COLD SWEAT (Cold sweat), CARDIAC MURMUR (Worsened heart murmur), AORTIC VALVE INCOMPETENCE (Aortic valve was not opening enough) and COVID-19 (Patient experienced positive for COVID-19 virus / COVID-19 infection) in an 82-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) solution for injection for Rheumatoid arthritis. The patient's past medical history included Ex-alcohol user (Couple of bottles of beer and two glasses of martini) in 1981, Chest pain in 2013, Tiredness (Age related tiredness) in 2016, Weight loss from April 2020 to 2020, Pneumonia from April 2020 to May 2020, COVID-19 from 20-Apr-2020 to May 2020, Diarrhea from April 2020 to May 2020 and Cough from April 2020 to May 2020. Concurrent medical conditions included Arthritic pains (Arthritis pain on hands) since 2014, Non-smoker, Perfume sensitivity (Perfume allergy manifested by sneezing), Heart murmur, Rheumatoid arthritis, Alcohol allergy (Whiskey or any alcohol, associated manifestation with stomach upset and diarrhea), Vegetable allergy (Onion, associated manifestation with stomach upset and diarrhea), Allergy NOS (Garlic, associated manifestation with stomach upset and diarrhea), Food allergy (Piece of cheese, associated manifestation with stomach upset and diarrhea) and Fruit allergy (Berry, associated manifestation with stomach upset and diarrhea). Concomitant products included LIDOCAINE for Arthritic pains, AMLODIPINE MESILATE for Chest pain, CLOPIDOGREL BISULFATE (PLAVIX) for Heart disorder, VITAMIN B COMPLEX for Leg cramps, PARACETAMOL (TYLENOL) for Pain, DIAZEPAM for Poor sleep, CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Supplementation therapy, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation, RANOLAZINE (RANEXA [RANOLAZINE]), BISOPROLOL FUMARATE (CONCOR), FINASTERIDE (PROSCAR), ASPIRIN [ACETYLSALICYLIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization). On 27-Apr-2021, the patient experienced PNEUMONIA (Pneumonia on left lung) (seriousness criteria hospitalization and medically significant) and COVID-19 (Patient experienced positive for COVID-19 virus / COVID-19 infection) (seriousness criterion hospitalization). In 2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization) and COLD SWEAT (Cold sweat) (seriousness criterion hospitalization). In July 2021, the patient experienced AORTIC VALVE INCOMPETENCE (Aortic valve was not opening enough) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CHEST PAIN (Recurrent chest pain) (seriousness criterion hospitalization), ARTHRALGIA (Arthritic pains) (seriousness criterion hospitalization), CARDIAC MURMUR (Worsened heart murmur) (seriousness criterion hospitalization) and VACCINATION FAILURE (Vaccination failure). The patient was hospitalized from 27-Apr-2021 to 14-May-2021 due to ARTHRALGIA, CARDIAC MURMUR, CHEST PAIN, COLD SWEAT, COVID-19, PNEUMONIA and PYREXIA. On 29-May-2021, COVID-19 (Patient experienced positive for COVID-19 virus / COVID-19 infection) had resolved. At the time of the report, PNEUMONIA (Pneumonia on left lung), DYSPNOEA (Difficulty breathing), CHEST PAIN (Recurrent chest pain) and ARTHRALGIA (Arthritic pains) had not resolved, PYREXIA (Fever), COLD SWEAT (Cold sweat) and VACCINATION FAILURE (Vaccination failure) outcome was unknown and CARDIAC MURMUR (Worsened heart murmur) and AORTIC VALVE INCOMPETENCE (Aortic valve was not opening enough) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2020, Nasopharyngeal swab: Positive for COVID-19 virus. On 27-Apr-2021, Chest X-ray: Pneumonia on left lung. On 27-Apr-2021, Nasopharyngeal swab: Positive for COVID-19 virus. On 11-May-2021, Nasopharyngeal swab: Positive for COVID-19 virus and Negative for COVID-19 virus. In 2021, Electrocardiogram: Worsened heart murmur. In July 2021, Echocardiogram: Valve was not opening enough. The reporter stated that the arthritis pain on hands was continuing on an unknown date. Since 2016, the patient was being monitored because of the heart valve that was not closing enough and had been having electrocardiogram annually. On Apr 2020 the patient experienced change with sense of taste and smell and got recovered in 2020. He was hospitalized from 27 Apr 2020 until 14 May 2020 due to Covid 19 infection. He received one unit of antibody transfusion for Covid 19 and was treated with an unknown antibiotic for pneumonia. The patient was brought to the hospital and was tested positive for the COVID-19 virus and pneumonia in his left lung after some tests. He got admitted on 27 Apr 2021, spent eight days in the intensive care unit and was hooked to some oxygen. He was placed on a side lying position and that he was off Humira while admitted. On 14 May 2021, patient was sent to home. He also had recurrent chest pains so, had seen for a follow up and had an echocardiogram which showed that the aortic valve was not opening enough hence was advised to have an aortic valve replacement procedure. Due to this, Humira was put on hold for three weeks prior to the heart valve replacement surgery on 09 Nov 2021 and planned to resume on Humira two weeks after. It was unknown if patient was enrolled in a COVID-19 vaccine trial. 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. This spontaneous case concerns 82-years-old male patient with concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA) ,who experienced the unexpected, serious (hospitalization) AESI event of COVID-19 and unexpected serious (hospitalization) events of Pneumonia (medically significant), Dyspnoea, Chest pain, Arthralgia, Pyrexia, Cold sweat, Cardiac murmur and Aortic valve incompetence. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. It was reported that patient had arthritis pain on hands since an unknown date. Since 2016, the patient was being monitored because of the heart valve that was not closing enough and had been having electrocardiogram annually. The patient was hospitalized and was tested positive for the COVID-19 virus and pneumonia in his left lung after some tests. He got admitted on 27 Apr 2021, spent eight days in the intensive care unit with oxygen. He was placed on a side lying position and that he was off Humira while admitted. He also had recurrent chest pains so, had seen for a follow up and had an echocardiogram which showed that the aortic valve was not opening enough hence was advised to have an aortic valve replacement procedure. Due to this, Humira was put on hold for three weeks prior to the heart valve replacement surgery on 09 Nov 2021 and planned to resume on Humira two weeks after. The investigation showed that Nasopharyngeal swab was Positive for COVID-19 virus, Chest X-ray showed Pneumonia on left lung and Electrocardiogram showed Worsened heart murmur. Echocardiogram with Valve was not opening enough. The event of COVID-19 was resolved ,the event cardiac murmur and Aortic valve incompetence were resolving and other events were unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information. Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Follow up document was received and contains no new information. Sender's Comments: This spontaneous case concerns 82-years-old male patient with concurrent medical condition of Rheumatoid Arthritis that was treated with ADALIMUMAB (HUMIRA), who experienced the unexpected, serious (hospitalization) AESI event of COVID-19 and unexpected serious (hospitalization) events of Pneumonia(medically significant), Dyspnoea, Chest pain, Arthralgia, Pyrexia, Cold sweat, Cardiac murmur and Aortic valve incompetence. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. It was reported that patient had arthritis pain on hands since an unknown date. Since 2016, the patient was being monitored because of the heart valve that was not closing enough and had been having electrocardiogram annually. The patient was hospitalized and was tested positive for the COVID-19 virus and pneumonia in his left lung after some tests. He got admitted on 27 Apr 2021, spent eight days in the intensive care unit with oxygen. He was placed on a side lying position and that he was off Humira while admitted. He also had recurrent chest pains so, had seen for a follow up and had an echocardiogram which showed that the aortic valve was not opening enough hence was advised to have an aortic valve replacement procedure. Due to this, Humira was put on hold for three weeks prior to the heart valve replacement surgery on 09 Nov 2021 and planned to resume on Humira two weeks after. The investigation showed that Nasopharyngeal swab was Positive for COVID-19 virus, Chest X-ray showed Pneumonia on left lung and Electrocardiogram showed Worsened heart murmur. Echocardiogram with Valve was not opening enough. The event of COVID-19 was resolved, the event cardiac murmur and Aortic valve incompetence were resolving and other events were unknown. The medical history of Rheumatoid Arthritis remains a confounder to the event's Rheumatoid arthritis flare up. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.