Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID symptoms came back after finishing the tablets, have relapsed and sick again with COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID symptoms came back after finishing the tablets, have relapsed and sick again with COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 008B21A and 042B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    Concurrent medical conditions included Pollen allergy, Allergic to cats, Allergy to nuts (Hazelnuts), Fruit allergy (Peaches, sunflower seeds), Dust allergy, Allergy to molds, Grass allergy, Breast cancer and GERD. Concomitant products included LETROZOLE from 01-Jun-2020 to an unknown date for an unknown indication.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 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 COVID-19 (COVID symptoms came back after finishing the tablets, have relapsed and sick again with COVID) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID symptoms came back after finishing the tablets, have relapsed and sick again with COVID) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. Not Provided          The patient race was reported. Concomitant medication information included the patient had letrozole (proprietary medicinal product name: Teva).  Company comment: This spontaneous case concerns a 44-year-old female patient with no relevant medial history reported, who experienced the unexpected non-serious ADR Covid-19, approximately 5 months after receiving the 3rd dose of mRNA-1273 vaccine. Additionally, Drug ineffective was also reported. The patient had received a course of Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19 but she felt sick again and had symptoms of Covid (not specified). Details of clinical course, investigation reports and treatment were not provided. The patient had taken 3 mRNA-1273 doses within appropriate schedule and the last dose was 5months prior to the events. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 44-year-old female patient with no relevant medial history reported, who experienced the unexpected non-serious ADR Covid-19, approximately 5 months after receiving the 3rd dose of mRNA-1273 vaccine. Additionally, Drug ineffective was also reported. The patient had received a course of Paxlovid (Nirmatrelvir + Ritonavir) for Covid-19 but she felt sick again and had symptoms of Covid (not specified). Details of clinical course, investigation reports and treatment were not provided. The patient had taken 3 mRNA-1273 doses within appropriate schedule and the last dose was 5months prior to the events. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.