Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Feeling abnormal, Paralysis, SARS-CoV-2 test
Clinical narrative: Positive for COVID-I9; Patient felt rough a fewdays before ravulizumab was due.; Palsy; This spontaneous case was reported by a patient and describes the occurrence of PARALYSIS (Palsy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) concentrate for solution for infusion for Paroxysmal nocturnal haemoglobinuria and COVID-19 VACCINE for COVID-19 immunization.    Previously administered products included for Paroxysmal nocturnal haemoglobinuria: Soliris. Past adverse reactions to the above products included No adverse event with Soliris. Concurrent medical conditions included Paroxysmal nocturnal haemoglobinuria.   In May 2019, the patient started RAVULIZUMAB (ULTOMIRIS [RAVULIZUMAB]) (Intravenous) at an unspecified dose. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE (unknown route) 1 dosage form. On an unknown date, received second dose of COVID-19 VACCINE (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PARALYSIS (Palsy) (seriousness criterion medically significant). In June 2022, the patient experienced COVID-19 (Positive for COVID-I9) and FEELING ABNORMAL (Patient felt rough a fewdays before ravulizumab was due.). In 2021, PARALYSIS (Palsy) had resolved. In June 2022, COVID-19 (Positive for COVID-I9) had resolved. At the time of the report, FEELING ABNORMAL (Patient felt rough a fewdays before ravulizumab was due.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) positive and (Negative) negative.   No concomitant medications were reported. On an unspecified date, the patient got two COVID shots and had a rough time after the second one.  Patient had a terrible reaction that involved having palsy for three days.  He did not feel as well after infusion (MALAISE) and sometimes needed a nap. The patient reported that he was feeling under the weather in Mar-2022 but was fine at the time of the report. It was reported that patient was supposed to get infused in June but tested positive for COVID-I9 and had to delay infusion for eight days.  Patient got COVID-19 infection, it was like a 'bad cold' for about two days and then subsided down to a mild cold for another few days (nasopharyngitis). The patient stated symptoms resolved and he was able to get infused once he tested negative for the virus. The patient stated that in general felt better on the eculizumab than on the ravulizumab. The patient reported that he felt rough a few days before ravulizumab was due and after.  No treatment medication were reported.  company comment-This spontaneous case concerns an adult male patient with current condition of Paroxysmal Nocturnal Haemoglobinuria who experienced the unexpected, serious (medically significant) event of Paralysis and unexpected non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) after receiving an unknown dose number of mRNA-1273. Two doses of unspecified COVID-19 vaccines were administered on unknown interval prior to mRNA-1273 vaccination. The patient developed palsy which lasted for three days on the same year of mRNA-1273 vaccination. The clinical course, diagnostic evaluation and treatment details of the event Paralysis were not reported. On unknown number of months after mRNA-1273 vaccination, patient developed nasopharyngitis and tested positive for COVID-19. COVID-19 has recovered after testing negative to COVID-19 test on unknown number of days after the event onset. Paroxysmal Nocturnal Hemoglobinuria is associated with increased risk for thrombosis thus considered a confounder for the event paralysis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with current condition of Paroxysmal Nocturnal Haemoglobinuria who experienced the unexpected, serious (medically significant) event of Paralysis and unexpected non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) after receiving an unknown dose number of mRNA-1273. Two doses of unspecified COVID-19 vaccines were administered on unknown interval prior to mRNA-1273 vaccination. The patient developed palsy which lasted for three days on the same year of mRNA-1273 vaccination. The clinical course, diagnostic evaluation and treatment details of the event Paralysis were not reported. On unknown number of months after mRNA-1273 vaccination, patient developed nasopharyngitis and tested positive for COVID-19. COVID-19 has recovered after testing negative to COVID-19 test on unknown number of days after the event onset. Paroxysmal Nocturnal Hemoglobinuria is associated with increased risk for thrombosis thus considered a confounder for the event paralysis. The benefit-risk relationship of mRNA-1273 is not affected by this report.