Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19
Clinical narrative: COVID sx seem to be back/Extreme gastro/Bad taste/New sx is altered sense of taste/Malaise/congestion/Cough/Aches/Diarrhea/Headache/Nausea; This spontaneous case was reported by a patient and describes the occurrence of SUSPECTED COVID-19 (COVID sx seem to be back/Extreme gastro/Bad taste/New sx is altered sense of taste/Malaise/congestion/Cough/Aches/Diarrhea/Headache/Nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy (Unknown drug). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.   On 08-Apr-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced SUSPECTED COVID-19 (COVID sx seem to be back/Extreme gastro/Bad taste/New sx is altered sense of taste/Malaise/congestion/Cough/Aches/Diarrhea/Headache/Nausea). At the time of the report, SUSPECTED COVID-19 (COVID sx seem to be back/Extreme gastro/Bad taste/New sx is altered sense of taste/Malaise/congestion/Cough/Aches/Diarrhea/Headache/Nausea) had not resolved.            The patient took other medications/products within 2 weeks of starting COVID-19 treatment.   The patient did not had fever so far.   No treatment medication was provided.  Company Comment: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 13 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 7 days. 1 day after completing the treatment, COVID symptoms recurred (extreme gastro, nausea, bad taste, diarrhea, malaise, headache, congestion, cough, aches) with altered sense of taste but afebrile. The event had not resolved at the time of the report. It should be noted that the dose was reported as second dose however, there was no information regarding the first dose of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 55-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 13 months after receiving a dose of mRNA-1273 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 7 days. 1 day after completing the treatment, COVID symptoms recurred (extreme gastro, nausea, bad taste, diarrhea, malaise, headache, congestion, cough, aches) with altered sense of taste but afebrile. The event had not resolved at the time of the report. It should be noted that the dose was reported as second dose however, there was no information regarding the first dose of COVID-19 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.