Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Fatigue, Lung disorder, Pyrexia
Clinical narrative: COVID-19; felling really sick in my lungs; slight fever; very tired; Bad metallic sour taste in my mouth after first dose of plaxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), LUNG DISORDER (felling really sick in my lungs), DYSGEUSIA (Bad metallic sour taste in my mouth after first dose of plaxlovid), PYREXIA (slight fever) and FATIGUE (very tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 025A21A and 025AUA) for COVID-19 vaccination.     The patient's past medical history included Bronchitis (got bronchitis easily). Concurrent medical conditions included Asthma.   On 02-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021 at 1:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced DYSGEUSIA (Bad metallic sour taste in my mouth after first dose of plaxlovid). On an unknown date, the patient experienced COVID-19 (COVID-19), LUNG DISORDER (felling really sick in my lungs), PYREXIA (slight fever) and FATIGUE (very tired). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-Apr-2022 to 30-Apr-2022 at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had resolved, LUNG DISORDER (felling really sick in my lungs), PYREXIA (slight fever) and FATIGUE (very tired) had not resolved and DYSGEUSIA (Bad metallic sour taste in my mouth after first dose of plaxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Tested negative on day 6 and negative (Negative) The patient was again retested and the result came up as negative..         It was reported that the patient did not took any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient reported that after few doses of Paxlovid symptoms felt better and tested negative on day 6. After that the patient tried to go back about her life but due to sick feeling in lungs and slight fever on day 9, she thought she had COVID again. The patient reported that it was so bad that she went back to the physician who prescribed steroids. On day 2 of steroids, she started to slowly feel better, but very tired. The patient also used unspecified steroids device on 06-May-2022. The patient was retested and result came up as negative, but she was not well yet. Company comment: This spontaneous case concerns a 68-year-old, male patient with medical history of Bronchitis, who experienced the unexpected, non-serious AESI of COVID-19. The date of onset of the event COVID was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The third dose of mRNA-1273 was given on November 5, 2021, the initial two doses were given approximately 8 months prior, the interval between the two doses is 45 days. The patient's medical history of Bronchitis could be a confounder to the event COVID-19. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-561923 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with medical history of Bronchitis, who experienced the unexpected, non-serious AESI of COVID-19. The date of onset of the event COVID was not specified in respect to the administration of a dose of mRNA-1273, hence latency could not be assessed. The third dose of mRNA-1273 was given on November 5, 2021, the initial two doses were given approximately 8 months prior, the interval between the two doses is 45 days. The patient's medical history of Bronchitis could be a confounder to the event COVID-19. Details of concomitant medications, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.