Reporte zur Charge AS71UOL

Symptomtext

neuropathy/being worse at night/severe neuropathy; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy/being worse at night/severe neuropathy) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71UOL) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation (Past medical history of A fib,) and Back discomfort. Concurrent medical conditions included Drug allergy, Osteoarthritis and Neuropathy since 21-Jan-2021. On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2022, the patient experienced NEUROPATHY PERIPHERAL (neuropathy/being worse at night/severe neuropathy) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Condition aggravated). The patient was treated with GABAPENTIN for Neuropathy, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy/being worse at night/severe neuropathy) and CONDITION AGGRAVATED (Condition aggravated) had not resolved. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. No concomitant information was reported. It was reported that 5 days after the 1st vaccine the patient developed severe neuropathy which she still had and was on medication for it. Patient was taking Gabapentin. At the time there was not reported of that side effects. The reporter stated after every booster they get the side effect neuropathy being worsened at night after the 4th dose and after the booster. Next one 5 days after the first dose was when they neuropathy and it was severe but never went away. The patient saw a neurologist about a month later. Company comment: This spontaneous case concerns a female patient of an unknown age, with current condition of neuropathy, who experienced the unexpected and serious (medically significant) event of NEUROPATHY and condition aggravated, on the night of the fourth dose of mRNA-1273.222 vaccine, and after an unspecified time interval after the booster dose with mRNA-1273.222 vaccine. She developed neuropathy 5 days after the 1st dose with mRNA-1273 vaccine which worsened after the last doses. Patient was taking Gabapentin. The event had not resolved. No further clinical information was available for medical review. The benefit-risk relationship of mRNA- 1273.222 vaccine is not affected by this report. This case was linked to MOD-2021-016971 (Patient Link).