Age: 71.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood urine present, Computerised tomogram, Fall, Joint swelling, Loss of consciousness
Clinical narrative: Stoma site hypergranulation; Sleep disturbance; Strength loss of; Swelling of feet; Stiffness; Ankles swollen; Fall; Loss of consciousness; Fall; Agitated; Elevated BP; Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness), the first episode of FALL (Fall), BLOOD URINE PRESENT (Blood in urine), BLOOD PRESSURE INCREASED (Elevated BP), AGITATION (Agitated), STOMA SITE HYPERGRANULATION (Stoma site hypergranulation), SLEEP DISORDER (Sleep disturbance), ASTHENIA (Strength loss of), PERIPHERAL SWELLING (Swelling of feet), MUSCULOSKELETAL STIFFNESS (Stiffness), JOINT SWELLING (Ankles swollen) and the second episode of FALL (Fall) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031L20A) for COVID-19 vaccination.    Co-suspect product included non-company product CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease.    Concurrent medical conditions included Frequency urinary, Labile blood pressure and Parkinson's disease. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) for Brain disorder NOS, GABAPENTIN for Leg pain, CARBIDOPA MONOHYDRATE, LEVODOPA (CARBIDOPA + LEVODOPA) from 06-Aug-2021 to an unknown date for Parkinson's disease, MELATONIN (MELATONIN GUMMIES) for Sleep disorder, QUETIAPINE, MIRABEGRON (MYRBETRIQ) and TROSPIUM for an unknown indication.   In 2009, the patient started CARBIDOPA, LEVODOPA (DUOPA) (unknown route) percutaneous j-tube. In 2015, CARBIDOPA, LEVODOPA (DUOPA) (unknown route) dosage was changed to percutaneous j-tube. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2020, the patient experienced BLOOD URINE PRESENT (Blood in urine) (seriousness criterion medically significant). In 2021, the patient experienced BLOOD PRESSURE INCREASED (Elevated BP) (seriousness criterion medically significant). In June 2021, the patient experienced AGITATION (Agitated) (seriousness criterion medically significant). In August 2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and the first episode of FALL (Fall) (seriousness criterion medically significant). On an unknown date, the patient experienced STOMA SITE HYPERGRANULATION (Stoma site hypergranulation) (seriousness criterion medically significant), SLEEP DISORDER (Sleep disturbance) (seriousness criterion medically significant), ASTHENIA (Strength loss of) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling of feet) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen) (seriousness criterion medically significant) and the second episode of FALL (Fall) (seriousness criterion medically significant). In August 2021, LOSS OF CONSCIOUSNESS (Loss of consciousness) had resolved. At the time of the report, BLOOD URINE PRESENT (Blood in urine), BLOOD PRESSURE INCREASED (Elevated BP), STOMA SITE HYPERGRANULATION (Stoma site hypergranulation), SLEEP DISORDER (Sleep disturbance), ASTHENIA (Strength loss of), PERIPHERAL SWELLING (Swelling of feet), MUSCULOSKELETAL STIFFNESS (Stiffness), JOINT SWELLING (Ankles swollen) and the last episode of FALL (Fall) outcome was unknown and AGITATION (Agitated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood test: normal. In 2021, Blood pressure measurement: elevated. In August 2021, Blood test: normal. In August 2021, Computerised tomogram: normal. In August 2021, X-ray: normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The reporters causality for the events of loss of consciousness, blood in urine, blood pressure elevated and agitated with duopa was no reasonable possibility. The reporters causality for the events of falls, J tube knotted, fell about 20 times, possible hype granulation tissue around the stoma, sleep disturbance overnight, incapacitated, feet and ankle very swollen was not provided.    for the events of loss of consciousness, blood in urine, blood pressure elevated and agitated, falls, J tube knotted, fell about 20 times, possible hype granulation tissue around the stoma, sleep disturbance overnight, incapacitated, feet and ankle very swollen was no reasonable possibility with duopa.    Primary reporter did not had the lot number information, because the packaging was discarded.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 71-year-old, male patient with relevant medical history of Advanced Parkinson's disease treated with the co-suspect product Duopa (carbidopa/levodopa), status post percutaneous J-tube insertion, history of Labile blood pressure and history of concomitant intake of Aricept (donepezil hydrochloride) for brain function, who experienced the unexpected, serious (medically significant) events of loss of consciousness, fall (LLT: fall), blood urine present, blood pressure increased, agitation, stoma site hypergranulation, sleep disorder, asthenia, peripheral swelling (swelling of feet), musculoskeletal stiffness, joint swelling (ankles swollen) and fall (LLT: falling). The event blood urine present occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in 2020, hence, the onset latency could not be assessed. The event blood pressure increased occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The event agitation occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in Jun2021, hence, the onset latency could not be assessed. The events loss of consciousness and fall (LLT: fall) occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in Aug2021, hence, the onset latency could not be assessed. The other events also occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. The event onset dates were not provided, hence, the onset latency also could not be assessed. It was reported that the patient had slight blood in his urine in 2020. The patient was supposed to undergo an unknown bladder procedure, however, the patient had an elevated blood pressure (measurement was not provided), hence, the surgery was postponed. The outcomes of the events were unknown. Approximately 3 months after receiving the second dose of the mRNA-1273 vaccine, it was reported that the patient had been very agitated due to their move and loss of personal belongings. However, the patient's wife could not assess if this was related to the vaccine. After approximately 2 months, the patient began falling for about 20 times. On one occasion, he lost consciousness for about 10 to 15 seconds, and was brought to the Emergency room (ER). An unspeciifed blood work, two Computerized Tomogram scans and X-ray (unknown body part) were done which showed normal results. Of note, the reporter stated that the patient had been falling because he would not use his walker. On unknown dates, the patient also experienced possible hypergranulating tissue around the stoma of the percutaneous J-tube, sleep disturbance, feet and ankle swelling, and muscles were 'stiff as a board'. At the time of the report, the patient was brought to the ER again. No further details were provided. The medical history of Advanced Parkinson's disease remains a confounder for the event musculoskeletal stiffness which is a common symptom of the disease, and for the events agitation and sleep disorder which are possible complications of the disease. The history of Labile blood pressure remains a confounder for the event blood pressure increased. The concomitant intake of Aricept remains a confounder for the event asthenia which is a common side effect of the medication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old, male patient with relevant medical history of Advanced Parkinson's disease treated with the co-suspect product Duopa (carbidopa/levodopa), status post percutaneous J-tube insertion, history of Labile blood pressure and history of concomitant intake of Aricept (donepezil hydrochloride) for brain function, who experienced the unexpected, serious (medically significant) events of loss of consciousness, fall (LLT: fall), blood urine present, blood pressure increased, agitation, stoma site hypergranulation, sleep disorder, asthenia, peripheral swelling (swelling of feet), musculoskeletal stiffness, joint swelling (ankles swollen) and fall (LLT: falling). The event blood urine present occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in 2020, hence, the onset latency could not be assessed. The event blood pressure increased occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in 2021, hence, the onset latency could not be assessed. The event agitation occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset date was reported as unspecified date in Jun2021, hence, the onset latency could not be assessed. The events loss of consciousness and fall (LLT: fall) occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in Aug2021, hence, the onset latency could not be assessed. The other events also occurred unknown number of days after receiving Duopa and unknown number of days after receiving the second dose of the mRNA-1273 vaccine. The event onset dates were not provided, hence, the onset latency also could not be assessed. It was reported that the patient had slight blood in his urine in 2020. The patient was supposed to undergo an unknown bladder procedure, however, the patient had an elevated blood pressure (measurement was not provided), hence, the surgery was postponed. The outcomes of the events were unknown. Approximately 3 months after receiving the second dose of the mRNA-1273 vaccine, it was reported that the patient had been very agitated due to their move and loss of personal belongings. However, the patient's wife could not assess if this was related to the vaccine. After approximately 2 months, the patient began falling for about 20 times. On one occasion, he lost consciousness for about 10 to 15 seconds, and was brought to the Emergency room (ER). An unspeciifed blood work, two Computerized Tomogram scans and X-ray (unknown body part) were done which showed normal results. Of note, the reporter stated that the patient had been falling because he would not use his walker. On unknown dates, the patient also experienced possible hypergranulating tissue around the stoma of the percutaneous J-tube, sleep disturbance, feet and ankle swelling, and muscles were 'stiff as a board'. At the time of the report, the patient was brought to the ER again. No further details were provided. The medical history of Advanced Parkinson's disease remains a confounder for the event musculoskeletal stiffness which is a common symptom of the disease, and for the events agitation and sleep disorder which are possible complications of the disease. The history of Labile blood pressure remains a confounder for the event blood pressure increased. The concomitant intake of Aricept remains a confounder for the event asthenia which is a common side effect of the medication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.