Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: during treatment had a seesaw effect of feeling better and then feeling worse. After third day of five-day regimen felt better. Day 8 after starting/ending treatment, symptoms have started to return; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (during treatment had a seesaw effect of feeling better and then feeling worse. After third day of five-day regimen felt better. Day 8 after starting/ending treatment, symptoms have started to return) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included ATORVASTATIN from 24-May-2022 to an unknown date for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (during treatment had a seesaw effect of feeling better and then feeling worse. After third day of five-day regimen felt better. Day 8 after starting/ending treatment, symptoms have started to return). At the time of the report, COVID-19 (during treatment had a seesaw effect of feeling better and then feeling worse. After third day of five-day regimen felt better. Day 8 after starting/ending treatment, symptoms have started to return) outcome was unknown.            It was reported that the Device Date was 01-Jun-2022. It was reported that the patient was taking medications within 2 weeks of starting COVID-19. No treatment medications were provided by the reporter.   Co-suspect Pfizer (Unspecified name, batch number 0069-1085-30) started on 24-May-2022 and discontinued on 29-May-2022 for treatment of COVID-19.  Company comment This spontaneous case reported by a patient, concerns a 69-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 on an unknown date, about 7 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received an unknown treatment from Pfizer company drug from 24 May to 29 May 2022 for 5 days, for covid 19 treatment. It was reported that during treatment she had a seesaw effect of feeling better and then feeling worse. The patient felt better after third day of the five-day regimen. On Day 8 after starting/ending the treatment, symptoms had started to return. Patient received the primary 2 doses with Moderna vaccines, about an year ago prior to 3 dose, with no adverse events reported for the previous Moderna vaccines. Advanced Age of the subject and the ongoing Covid 19 pandemia are confounders. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case reported by a patient, concerns a 69-year-old female patient with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 on an unknown date, about 7 months after receiving the 3 dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received an unknown treatment from Pfizer company drug from 24 May to 29 May 2022 for 5 days, for covid 19 treatment. It was reported that during treatment she had a seesaw effect of feeling better and then feeling worse. The patient felt better after third day of the five-day regimen. On Day 8 after starting/ending the treatment, symptoms had started to return. Patient received the primary 2 doses with Moderna vaccines, about an year ago prior to 3 dose, with no adverse events reported for the previous Moderna vaccines. Advanced Age of the subject and the ongoing Covid 19 pandemia are confounders. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.