Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Fatigue, Nausea, Parkinson's disease
Clinical narrative: Parkinsons required treatment with medicine after vaccine, previously was under control; constipation; fatigue; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (Parkinsons required treatment with medicine after vaccine, previously was under control), CONSTIPATION (constipation), FATIGUE (fatigue) and NAUSEA (nausea) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included MACROGOL 3350 (MIRALAX), LINACLOTIDE (LINZESS), DOMPERIDONE, MAGNESIUM CITRATE, CANNABIDIOL (CBD OIL), ESCITALOPRAM OXALATE (LEXAPRO) and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-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 experienced PARKINSON'S DISEASE (Parkinsons required treatment with medicine after vaccine, previously was under control), CONSTIPATION (constipation), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, PARKINSON'S DISEASE (Parkinsons required treatment with medicine after vaccine, previously was under control), CONSTIPATION (constipation), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.            The patient concomitants included THC Gummies. Treatment information was not provided.  Action taken with the mRNA-1273 in response to the event is not applicable.  Company Comment: This case concerns a 57-year-old male patient with relevant medical history of Parkinson's disease who experienced non-serious unexpected events of Parkinson's disease (Parkinson's disease aggravated), Fatigue, Nausea and Constipation. Temporal relationship is unknown as start date of the events was not provided. The rechallenge was not applicable. At the time of the report the events were still ongoing and no information regarding the clinical course of the events was provided. Causality for the event Parkinson's disease (Parkinson's disease aggravated) is confounded with patient's medical history of Parkinson's disease as it is a complex disease characterized by flares which can be triggered by various environmental factors. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 57-year-old male patient with relevant medical history of Parkinson's disease who experienced non-serious unexpected events of Parkinson's disease (Parkinson's disease aggravated), Fatigue, Nausea and Constipation. Temporal relationship is unknown as start date of the events was not provided. The rechallenge was not applicable. At the time of the report the events were still ongoing and no information regarding the clinical course of the events was provided. Causality for the event Parkinson's disease (Parkinson's disease aggravated) is confounded with patient's medical history of Parkinson's disease as it is a complex disease characterized by flares which can be triggered by various environmental factors. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.