Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had 4 doses of the Moderna COVID-19 vaccine, tested positive for Covid/ Just a little achy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Had 4 doses of the Moderna COVID-19 vaccine, tested positive for Covid/ Just a little achy). At the time of the report, COVID-19 (Had 4 doses of the Moderna COVID-19 vaccine, tested positive for Covid/ Just a little achy) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Tested positive. No concomitant medications was reported. The patient informed that, received 4 doses of the Moderna COVID-19 vaccine and on an unknown date was tested positive for Covid. No treatment drug details was reported. Company Comment: This spontaneous case concerns a 74 year old male patient with no medical history reported, with Co-suspect non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, who experienced non-serious, unexpected, AESI of Covid 19 which occurred on an unknown date post vaccination with the dose 1 , 2, 3 and 4 of mRNA-1273 vaccine. This patient reported Covid and was on Paxlovid medication. She reported to have aching on left side of neck first, muscles aching  on whole back of neck so couldn't sleep because of aching and  couldn't turn left or right and couldn't lift. She took 2 tablets of Motrin which afforded relief. Outcome of the event was unknown. The age of this patient and the ongoing Covid 19 pandemic are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case concerns a 74 year old male patient with no medical history reported, with Co-suspect non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, who experienced non-serious, unexpected, AESI of Covid 19 which occurred on an unknown date post vaccination with the dose 1 , 2 , 3 and 4 of mRNA-1273 vaccine. This patient reported Covid and was on Paxlovid medication. She reported to have aching on left side of neck first, muscles aching on whole back of neck so couldn't sleep because of aching and couldn't turn left or right and couldn't lift. She took 2 tablets of Motrin which afforded relief. Outcome of the event was unknown. The age of this patient and the ongoing Covid 19 pandemic are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 (Moderna Covid 19 Vaccine) is not affected by this report.