Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19/COVID rebound; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19/COVID rebound) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A22B, 939904, 002C21A and 016B214) for COVID-19 prophylaxis.     He has lost about 50 to 60 lbs. in the last year and his medical records shows obese and he was on the high end of normal weight and he was not obese.  The patient's past medical history included Obesity. Concurrent medical conditions included Sleep apnea, Hearing aid user (Patient using hearing aids), Glaucoma (each eye for glaucoma) and Optic nerve disorder NOS (Optic eye nerve). Concomitant products included LATANOPROST for Glaucoma and Optic nerve disorder NOS.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for Covid-19/COVID rebound). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-Sep-2022 to 06-Sep-2022 for COVID-19 treatment, at a dose of 2 150 mg tablets of nirmatrelvir and one 100 mg tablet of ritonavir. At the time of the report, COVID-19 (tested positive for Covid-19/COVID rebound) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2022, SARS-CoV-2 test: (Positive) tested positive for Covid-19. On 06-Sep-2022, SARS-CoV-2 test: (Negative) Negative. On 09-Sep-2022, SARS-CoV-2 test: (Negative) Negative. On 10-Sep-2022, SARS-CoV-2 test: (Positive) had a slight positive test and each day after he had a very strong positive. On 12-Sep-2022, SARS-CoV-2 test: (Positive) yesterday he tested and had the strongest positive T line anytime since testing.. On 13-Sep-2022, SARS-CoV-2 test: (Positive) today he tested and had the strongest positive T line anytime since testing..         Patient weight was reported as 195 lbs. to 200 lbs.  Patient took no vitamins, and he had a Continuous positive airway pressure (CPAP) for sleep apnea.  On 01-Sep-2022, he tested positive for COVID-19, and he began taking Paxlovid that day and completed 5 days of Paxlvoid each morning and evening at 7am in the morning and 7 pm in the evening. On 06 and 09 Sep-2022, he tested negative and then on Saturday 10-Sep-2022 he had a slight positive test and each day after he had a very strong positive and his symptoms came back and were stronger than the first go around with COVID. The test result had a very slight positive and almost had to use a magnifying glass to see the positive. Further stated that, yesterday and today he tested and had the strongest positive T line anytime since testing. Patient stated, he started testing on 30-Aug-2022 and tested everyday day till yesterday and today. He experienced symptoms including chest congestion, sinus congestion, runny nose and general aching throughout the body and no digestive system issues at all. Patient was retried. On 06-Sep-2022, patient finished and had the empty package and threw out the package. He tested negative on first test and thought he was good to go and had the empty package. He had received dosage of 3 pills in a blister pack and was very clear and one blister pack for each day and then he called blister unit and one set of pills highlighted in blue and one set of pills highlighted in a beige color. Patient stated that, 100 mg for 2 and 300 mg. He took 3 pills in the morning and 3 pills in the evening: total of 500 mg. He started taking in 5 days of symptoms. Tuesday was first day of symptoms, and he started Paxlovid on Thursday so within 2 or 3 days of symptoms. He then said 2 medications and to took 300 mg which was 2 150 mg tablets of nirmatrelvir and one 100 mg tablet of ritonavir.  Company comment: This spontaneous case concerns a 62 year old male patient with relevant medical history of Obesity and sleep apnea on Continuous positive airway pressure (CPAP)  who experienced non-serious , unexpected , AESI  of Covid 19 . The event occurred 3 months 9 days post vaccination with the 4th dose of mRNA-1273 vaccine . The dose 1, dose 2 and dose 3  Covid 19  vaccine of this patient were all mRNA-1273 vaccine. The patient tested positive for Covid-19  on 01-09-2022. He reported  symptoms of chest congestion, sinus congestion, runny nose and general aching throughout the body and with  no digestive system issues .  He was treated with NIRMATRELVIR, RITONAVIR (Paxlovid ) 1 tab twice a day since day 1 of the illness which he completed for 5 days.  On the day 6 and day 9 of his illness he tested negative with Covid 19 however on the day 10 of illness he had a light positive test and each day after he had a very strong positive  test and his symptoms came back and were stronger than the first.  The age of this patient and the medical history of Obesity and Sleep apnea on CPAP  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 62 year old male patient with relevant medical history of Obesity and sleep apnea on Continuous positive airway pressure (CPAP)  who experienced non-serious , unexpected , AESI  of Covid 19 . The event occurred 3 months 9 days post vaccination with the 4th dose of mRNA-1273 vaccine . The dose 1, dose 2 and dose 3  Covid 19  vaccine of this patient were all mRNA-1273 vaccine. The patient tested positive for Covid-19  on 01-09-2022. He reported  symptoms of chest congestion, sinus congestion, runny nose and general aching throughout the body and with  no digestive system issues .  He was treated with NIRMATRELVIR, RITONAVIR (Paxlovid ) 1 tab twice a day since day 1 of the illness which he completed for 5 days.  On the day 6 and day 9 of his illness he tested negative with Covid 19 however on the day 10 of illness he had a light positive test and each day after he had a very strong positive  test and his symptoms came back and were stronger than the first.  The age of this patient and the medical history of Obesity and Sleep apnea on CPAP  are considered as confounders for the event. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.