Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 036B21A and 048A21A) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 01-Aug-2022 for COVID-19, at a dose of 2 times a day for 5 days and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On an unknown date, SARS-CoV-2 antibody test: Result: 16810. Concomitant medication information was not provided by the reporter. Patient experienced COVID symptoms like headache, bitter taste in mouth, loss of sense of taste and smell. Doctor recommended patient not to get second booster dose of the respective vaccines because antibody results was so good. Company comment: This is a spontaneous case concerning a 84-year-old, female patient with no reported medical history. Patient experienced the unexpected non-serious AESI event of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 29 days. The patient received third dose (booster) of mRNA-1273 vaccine with dosage interval of 205 days after the second dose of mRNA-1273 vaccine administration. The event Covid-19 occurred approximately 9 months and 5 days after the third dose (booster) of mRNA-1273 vaccine administration with positive Covid-19 test result. Patient received Nirmatrelvir + Ritonavir (Paxlovid) as treatment medication for Covid-19. However, after taking 1 dose of Nirmatrelvir + Ritonavir (Paxlovid) patient experienced bitter taste and lost her sense of smell and taste. It was reported that the patient experienced headache and patient took Paracetamol which provided relief. On unknown date, patient took SARS-CoV-2 antibody test with result of 16810 (no unit). The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 84-year-old, female patient with no reported medical history. Patient experienced the unexpected non-serious AESI event of Covid-19. The patient received first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 29 days. The patient received third dose (booster) of mRNA-1273 vaccine with dosage interval of 205 days after the second dose of mRNA-1273 vaccine administration. The event Covid-19 occurred approximately 9 months and 5 days after the third dose (booster) of mRNA-1273 vaccine administration with positive Covid-19 test result. Patient received Nirmatrelvir + Ritonavir (Paxlovid) as treatment medication for Covid-19. However, after taking 1 dose of Nirmatrelvir + Ritonavir (Paxlovid) patient experienced bitter taste and lost her sense of smell and taste. It was reported that the patient experienced headache and patient took Paracetamol which provided relief. No other information surrounding the event was reported. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.