Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Magnetic resonance imaging, Neck pain, Paraesthesia
Clinical narrative: difficult to walk; hard to pick up things; neurologist diagnosed as having Carpal Tunnel Syndrome, more svere on left than right; fluid in the lower quadrant; diabetes; Axonal neuropathy with stocking hypoethesia to pin and absent vibration in his feet.; Felt generally weak; Pain in neck; paresthesia in his lower extrimities; left hand went numb/ right hand went numb/ his legs and feet up to his knees went numb, bilateral ullnar neuropathy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASCITES (fluid in the lower quadrant) and DIABETES MELLITUS (diabetes) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Carpal tunnel syndrome (diagnosed with Carpal Tunnel Syndrome in the past), Atrial fibrillation (status post modified maze procedure 2008, not anticoagulated.), Surgery, Shoulder operation (left shoulder surgery) in 2020 and Cox-Maze procedure (status post modified maze procedure, not anticoagulated) in 2008. Concurrent medical conditions included Drug allergy (Lipitor (atorvastatin) - 25 years ago, the patient experienced a similar numbness after taking Lipitor and once stopped the Lipitor, the numbness resolved) since 1996, Allergy to antibiotic (Flagyl (metronidazole)) and Chronic back pain (He has seen pain management physician for some time). Concomitant products included ALLOPURINOL, CELECOXIB (CELEBREX), LEVOTHYROXINE SODIUM (SYNTHROID), POTASSIUM, TESTOSTERONE, CARVEDILOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HYPOAESTHESIA (left hand went numb/ right hand went numb/ his legs and feet up to his knees went numb, bilateral ullnar neuropathy). On 18-Jun-2021, the patient experienced PARAESTHESIA (paresthesia in his lower extrimities) and NECK PAIN (Pain in neck). On an unknown date, the patient experienced ASCITES (fluid in the lower quadrant) (seriousness criterion medically significant), DIABETES MELLITUS (diabetes) (seriousness criterion medically significant), GAIT DISTURBANCE (difficult to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to pick up things), CARPAL TUNNEL SYNDROME (neurologist diagnosed as having Carpal Tunnel Syndrome, more svere on left than right), AXONAL NEUROPATHY (Axonal neuropathy with stocking hypoethesia to pin and absent vibration in his feet.) and ASTHENIA (Felt generally weak). The patient was treated with GABAPENTIN ongoing since an unknown date for Adverse event, at a dose of 300 milligram twice a day and PREDNISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ASCITES (fluid in the lower quadrant), DIABETES MELLITUS (diabetes), HYPOAESTHESIA (left hand went numb/ right hand went numb/ his legs and feet up to his knees went numb, bilateral ullnar neuropathy), GAIT DISTURBANCE (difficult to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to pick up things), CARPAL TUNNEL SYNDROME (neurologist diagnosed as having Carpal Tunnel Syndrome, more svere on left than right), PARAESTHESIA (paresthesia in his lower extrimities), AXONAL NEUROPATHY (Axonal neuropathy with stocking hypoethesia to pin and absent vibration in his feet.), ASTHENIA (Felt generally weak) and NECK PAIN (Pain in neck) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2017, Magnetic resonance imaging: epidural fat narrowing at canal l3-l4 (abnormal) Some epidural fat narrowing at canal L3-L4, no central canal narrowing at L4-L5. L5-S1 there was a focal posterior osteophyte paracentral to the right, which contacted the descending right S1 nerve root and serve left and mild right foraminal narrowing.. On 18-Jun-2021, Blood glucose: 158 (High) 158 mg/dL. On 18-Jun-2021, Blood magnesium: normal (normal) normal. On 18-Jun-2021, Blood pressure measurement: 130/70 (normal) 130/70. On 18-Jun-2021, Blood thyroid stimulating hormone: normal (normal) Normal. On 18-Jun-2021, Chest X-ray: normal (normal) No acute cardiopulmonary process.. On 18-Jun-2021, Computerised tomogram: no acute intracranial abnormality (normal) no acute intracranial abnormality. On 18-Jun-2021, Computerised tomogram spine: no spine fracture (normal) no spine fracture. On 18-Jun-2021, Full blood count: unremarkable (normal) unremarkable. On 18-Jun-2021, Hepatic enzyme: normal (normal) normal. On 18-Jun-2021, Ultrasound abdomen: revealed some fluids (abnormal) some fluids in the lower quadrant concerning ascites.         It was reported that the patient presented to the emergency room one month prior to the report because of the events and consulted a neurologist and two other physicians.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up received by safety 18-Aug-2021 added medical history, added laboratory data, added events and narrative was updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded