Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Reoccurrence of COVID symptoms at day 10. Runny nose, congestion, sneezing, coughing.; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Reoccurrence of COVID symptoms at day 10. Runny nose, congestion, sneezing, coughing.) and DRUG INEFFECTIVE (Lack of drug effect) in a 64-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 vaccination.    Concurrent medical conditions included Blood pressure high, Borderline diabetes, Allergy to molds and Seasonal allergy. Concomitant products included HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (BENICAR HCT), ESTRADIOL, METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), EZETIMIBE (ZETIA), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), ATENOLOL, VITAMIN D NOS and BIFIDOBACTERIUM INFANTIS (ALIGN) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 15-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 15-May-2022 at 10:00 AM, the patient experienced COVID-19 (Reoccurrence of COVID symptoms at day 10. Runny nose, congestion, sneezing, coughing.). At the time of the report, COVID-19 (Reoccurrence of COVID symptoms at day 10. Runny nose, congestion, sneezing, coughing.) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.             The patient experienced reoccurrence of COVID symptoms at day 10, runny nose, congestion, sneezing, coughing. No treatment was received.  Company Comment: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving the third dose of mRNA-1273 vaccine. The patient reported recurrence of COVID symptoms (runny nose, congestion, sneezing and coughing) after 10 days. The patient received prior treatment of Nirmatrelvir/Ritonavir for 5 days. The event had not resolved at the time of the report. Drug ineffective was also reported as an additional event. It should be noted that the primary doses of mRNA-1273 were administered in a 28-day interval and the third dose was given approximately 8 months after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 64-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 5 months after receiving the third dose of mRNA-1273 vaccine. The patient reported recurrence of COVID symptoms (runny nose, congestion, sneezing and coughing) after 10 days. The patient received prior treatment of Nirmatrelvir/Ritonavir for 5 days. The event had not resolved at the time of the report. Drug ineffective was also reported as an additional event. It should be noted that the primary doses of mRNA-1273 were administered in a 28-day interval and the third dose was given approximately 8 months after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.