Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 Omicron after receiving 2 primary doses and 2 booster doses of The Moderna Covid 19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid 19 Omicron after receiving 2 primary doses and 2 booster doses of The Moderna Covid 19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 038K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa drugs), Nickel sensitivity (Nickel), Allergy to gold (White gold) and Drug allergy (Ionamin).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, the patient experienced COVID-19 (Tested positive for Covid 19 Omicron after receiving 2 primary doses and 2 booster doses of The Moderna Covid 19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid 19 Omicron after receiving 2 primary doses and 2 booster doses of The Moderna Covid 19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.  It was reported that patient has experienced fever, yellow phlegmy, a horrible soar (sic)throat, felt a little tired, and headache. Patient took Tylenol as treatment and after she tested positive she took Paxlovid for 5 days. She reported that she took 3 at the same time and then 6 over night.  Company Comment: This spontaneous case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving the fourth dose (second booster dose) of the mRNA-1273 vaccine. Of note, the vaccination date was not provided, hence, the onset latency could not be assessed. The patient experienced fever (body temperature was not provided), yellow phlegm, 'horrible' sore throat, headache, and she also felt a little tired. The patient took Tylenol (paracetamol) of unspecified dose, frequency and duration. It was reported that the patient tested positive for the COVID-19 Omicron variant on 27Jul2022. After she tested positive, she took Paxlovid (nirmatrelvir, ritonavir) for 5 days (3 tablets at the same time and then 6 tablets overnight). The outcome of the event was unknown at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-624993 (Patient Link).; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with no relevant medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred unknown number of days after receiving the fourth dose (second booster dose) of the mRNA-1273 vaccine. Of note, the vaccination date was not provided, hence, the onset latency could not be assessed. The patient experienced fever (body temperature was not provided), yellow phlegm, 'horrible' sore throat, headache, and she also felt a little tired. The patient took Tylenol (paracetamol) of unspecified dose, frequency and duration. It was reported that the patient tested positive for the COVID-19 Omicron variant on 27Jul2022. After she tested positive, she took Paxlovid (nirmatrelvir, ritonavir) for 5 days (3 tablets at the same time and then 6 tablets overnight). The outcome of the event was unknown at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.