Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Cold symptoms; Cough; Headache; She lost her sense of taste; she contracted COVID-Disease; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Cold symptoms), COUGH (Cough), AGEUSIA (She lost her sense of taste), HEADACHE (Headache) and COVID-19 (she contracted COVID-Disease) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Dermatomyositis.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced COVID-19 (she contracted COVID-Disease). In July 2023, the patient experienced AGEUSIA (She lost her sense of taste). On 20-Jul-2023, the patient experienced NASOPHARYNGITIS (Cold symptoms), COUGH (Cough) and HEADACHE (Headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold symptoms), COUGH (Cough) and HEADACHE (Headache) had not resolved and AGEUSIA (She lost her sense of taste) and COVID-19 (she contracted COVID-Disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2023, SARS-CoV-2 test: (Positive) She had a COVID home test that expired a year ago. She took the expired test and it was positive. She thinks it may be a false positive..         Concomitant product use was not provided by the reporter.  It was reported that patient received 2 doses of Moderna COVID-19 vaccine in early 2021. She did not had her vaccination card handy. She thinks that her last shot was a Bivalent shot. She reports that many months after the 2 doses, in early 2022, she contracted COVID-Disease and took Paxlovid. Her immunologist told her that she had enough antibody, and she was protected and did not need vaccination again. On 20-Jul-2023, she came down with cold symptoms, Headache, raspatory symptoms and a light cough. She lost her sense of taste. She had a COVID home test that expired a year ago. She took the expired test, and it was positive.  Company comment: This is a spontaneous case concerning an 80-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of ageusia among other non-serious events. The event occurred after the second dose of mRNA-1273 vaccine. Patient had a COVID home test that expired a year ago, but she took it and it was positive. She thinks it may be a false positive. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome for the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.     Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case concerning an 80-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI of ageusia among other non-serious events. The event occurred after the second dose of mRNA-1273 vaccine. Patient had a COVID home test that expired a year ago, but she took it and it was positive. She thinks it may be a false positive. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome for the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.