Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment/ COVID symptoms rebounded; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment/ COVID symptoms rebounded) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Skin cancer and Drug allergy (Name of the drug was reported as no and reaction was allergy.). Concurrent medical conditions included Blood pressure high, Pre-diabetes and Migraine.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment/ COVID symptoms rebounded). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment/ COVID symptoms rebounded) had not resolved.            Concomitant medication was not provided. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 Vaccine. Device date was reported as 23-May-2022. It was reported that Paxlovid caused diarrhea. Also COVID symptoms rebounded after finishing Paxlovid. treatment. Device Date : 23-May-2022. Treatment information was not reported.  Company comment: This spontaneous case concerns a 76-year-old female patient with no relevant medical history reported, who experienced the unexpected, non-serious of COVID-19, approximately one month after a dose of mRNA-1273 vaccine; reported as fourth dose of her COVID-19 immunization schedules (patient´s third dose was also with mRNA-1273 vaccine; no information about previous vaccination schedule was provided). The report stated that the patient´s COVID-19 symptoms rebounded after finishing treatment with Paxlovid. It is also mentioned she had diarrhea which the patient considered related to treatment with Paxlovir. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76  year  old female patient with no relevant medical history reported, who experienced the unexpected, non  serious of COVID  19, approximately one month after a dose of mRNA-1273 vaccine; reported as fourth dose of her COVID  19 immunization schedules (patient´s third dose was also with mRNA  1273 vaccine; no information about previous vaccination schedule was provided). The report stated that the patient´s COVID  19 symptoms rebounded after finishing treatment with Paxlovid. It is also mentioned she had diarrhea which the patient considered related to treatment with Paxlovir. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.