Age: 80.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Malaise, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID (coronavirus disease)/malaise, and she could not get out of bed (malaise)/ Achy joints/Fever; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID (coronavirus disease)/malaise, and she could not get out of bed (malaise)/ Achy joints/Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.   On 24-Feb-2022, the patient started TREPROSTINIL SODIUM (TYVASO) (Inhalation use) at an unspecified dose four times per day. In 2022, TREPROSTINIL SODIUM (TYVASO) (Inhalation use) dosage was changed to at an unspecified dose four times per day and TREPROSTINIL SODIUM (TYVASO) (Inhalation use) dosage was changed to 54 microgram four times per day. On 11-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID (coronavirus disease)/malaise, and she could not get out of bed (malaise)/ Achy joints/Fever). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID (coronavirus disease)/malaise, and she could not get out of bed (malaise)/ Achy joints/Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         It was reported after taking Tyvaso medication on an unreported date in 2022, the patient was tested positive for COVID (coronavirus disease) (SARS-CoV-2 test positive), increased nausea, coughing and shortness of breath from baseline (nausea, cough, and dyspnea). It was reported, action taken with Tyvaso was not reported for the events of SARS-CoV-2 test positive, nausea, cough, and dyspnea. The reporter did not provide causality for the events of SARS-CoV-2 test positive, nausea, cough, and dyspnea.  Co-suspect medication included COVID-19 vaccine. An additional dosage regimen of 54 µg (9 breaths), QID via IH route was added to Tyvaso. On 12 Jul 2022, 4 months, and 19 days after initiating Tyvaso, she had achy joints (arthralgia), fever (pyrexia), malaise, and she could not get out of bed (malaise).  On 14 Jul 2022, 4 months, and 21 days after initiating Tyvaso, she went to emergency room and tested positive for COVID and was prescribed Paxlovid (nirmatrelvir). Action taken with Tyvaso was not reported for the events of arthralgia, pyrexia, and malaise. At the time of reporting, the outcome of arthralgia, pyrexia, and malaise was unknown. The reporter did not provide causality for the events of arthralgia, pyrexia, and malaise with Tyvaso. Company comment: This spontaneous case concerns an 80-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 3 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. It has been reported that the patient was tested positive for SARS-CoV-2 test on July 14, 2022, accompanied by nausea, cough and shortness of breath, she sought consult at an institution and was prescribed with Paxlovid. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 80-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 3 days after administration of fourth dose of mRNA-1273, there was no information provided regarding the initial three doses. It has been reported that the patient was tested positive for SARS-CoV-2 test on July 14, 2022, accompanied by nausea, cough and shortness of breath, she sought consult at an institution and was prescribed with Paxlovid. The outcome of the event is unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.