Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Completed course of Paxlovid. COVID symptoms gone. Tested negative by rapid 3 times within the following 5 days.; Day 7 symptoms recurred and tested positive by rapid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Completed course of Paxlovid. COVID symptoms gone. Tested negative by rapid 3 times within the following 5 days.) and COVID-19 (Day 7 symptoms recurred and tested positive by rapid) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 048F21A, 0R9L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Mild Hypertension), Hyperlipidemia (Mild hyperlipidemia), LBBB and Drug allergy (Allergy to Tegretol). Concomitant products included LOSARTAN, METOPROLOL, ROSUVASTATIN, VITAMIN B12 [VITAMIN B12 NOS] and ASA for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022, the patient experienced COVID-19 (Day 7 symptoms recurred and tested positive by rapid). On an unknown date, the patient experienced COVID-19 (Completed course of Paxlovid. COVID symptoms gone. Tested negative by rapid 3 times within the following 5 days.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19, at a dose of Treatment course with paxlovid/Pfizer. At the time of the report, COVID-19 (Completed course of Paxlovid. COVID symptoms gone. Tested negative by rapid 3 times within the following 5 days.) had resolved and COVID-19 (Day 7 symptoms recurred and tested positive by rapid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Tested negative by rapid 3 times following 5 days., negative (Negative) Tested negative by rapid 3 times following 5 days. and negative (Negative) Tested negative by rapid 3 times following 5 days.. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Day 7 symptoms recurred and tested positive by rapid..         Device Date was reported as 17-May-2022.  Company comment: This is a spontaneous case concerning a 75-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 (two events) which occurred 86 days after the fourth dose of mRNA-1273 vaccine and other event of COVID-19 on unknown date resolved after completing course of Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 (two events) which occurred 86 days after the fourth dose of mRNA-1273 vaccine and other event of COVID-19 on unknown date resolved after completing course of Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.