Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Relapse of COVID Symptoms-sore throat, congestion, extreme fatigue and post nasal drip) in a 28-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. The patient's past medical history included Drug allergy (Patient had experienced allergy to an unspecified historical drug of an unknown indication). Concurrent medical conditions included Polycystic ovarian syndrome, Bicuspid aortic valve and Hypercholesterolemia. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Relapse of COVID Symptoms-sore throat, congestion, extreme fatigue and post nasal drip) (seriousness criterion medically significant). At the time of the report, COVID-19 (Relapse of COVID Symptoms-sore throat, congestion, extreme fatigue and post nasal drip) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that the patient had experienced relapse of COVID symptoms and a unspecified congestion was also reported as a COVID symptom. It was reported that the patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. No treatment medications. Company Comment: This spontaneous case concerns a 28 year old female patient with relevant medical history of hypercholesterolemia, who experienced Non-serious, unexpected, AESI event of Covid-19 which occurred 4 months  7 days post vaccination with the third dose of mRNA-1273 vaccine. The information regarding the dose 1 and dose 2 Covid-19 vaccine of this patient was not reported. It was reported that the patient had experienced relapse of COVID symptoms and a unspecified congestion was also reported as a COVID symptom. Treatment given was the co-suspect non-company drug NIRMATRELVIR, RITONAVIR (PAXLOVID) given 6 days prior to the reported date of relapse of the Covid-19 of the patient. The dose and the frequency of this medication was not reported. Outcome of the event was reported as not resolved. The history of hypercholesterolemia, the co-suspect drug Paxlovid are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 28 year old female patient with relevant medical history of hypercholesterolemia, who experienced Non-serious, unexpected, AESI event of Covid-19 which occurred 4 months 7 days post vaccination with the third dose of mRNA-1273 vaccine. The information regarding the dose 1 and dose 2 Covid-19 vaccine of this patient was not reported. It was reported that the patient had experienced relapse of COVID symptoms and a unspecified congestion was also reported as a COVID symptom. Treatment given was the co-suspect non-company drug NIRMATRELVIR, RITONAVIR (PAXLOVID) given 6 days prior to the reported date of relapse of the Covid-19 of the patient. The dose and the frequency of this medication was not reported. Outcome of the event was reported as not resolved. The history of hypercholesterolemia, the co-suspect drug Paxlovid are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid-19 Vaccine) is not affected by this report.