Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paralysis, Vaccination site pain
Clinical narrative: legs became progressively weaker until the patient collapsed/became paralyzed from the neckdown and remained paralyzed for the next 5 months; leg weakness; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (legs became progressively weaker until the patient collapsed/became paralyzed from the neckdown and remained paralyzed for the next 5 months) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia, Diabetes, Neuropathy, Blood pressure high and High cholesterol. Concomitant products included TELMISARTAN, ATORVASTATIN, INSULIN GLARGINE (LANTUS), PREGABALIN (LYRICA), FINASTERIDE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), BACLOFEN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced VACCINATION SITE PAIN (sore left arm). On 15-Jul-2021, the patient experienced MUSCULAR WEAKNESS (leg weakness). In December 2021, the patient experienced PARALYSIS (legs became progressively weaker until the patient collapsed/became paralyzed from the neckdown and remained paralyzed for the next 5 months) (seriousness criterion medically significant). At the time of the report, PARALYSIS (legs became progressively weaker until the patient collapsed/became paralyzed from the neckdown and remained paralyzed for the next 5 months) was resolving and MUSCULAR WEAKNESS (leg weakness) and VACCINATION SITE PAIN (sore left arm) outcome was unknown.            The legs became progressively weaker until the patient collapsed on 02-Dec-2021. Currently the patient had some motion in his arms. Patient still paralyzed from the waist down. No treatment medications were reported.  Company comment: This spontaneous case concerns a 78-year-old male patient with relevant medical history of fibromyalgia and neuropathy, who experienced serious (medically significant) unexpected event of paralysis, that occurred approximately 5 months after the 2nd dose of the mRNA-1273.  Initially, 2 weeks after vaccination, the patient developed weakness in legs which further progressed until collapse and paralysis from neck down which lasted for 5 months. At the time of the report, the patient regained some motion in arms but was still paralyzed from waist down. The patient's relevant medical history is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-666606 (Patient Link).; Sender's Comments: This spontaneous case concerns a 78-year-old male patient with relevant medical history of fibromyalgia and neuropathy, who experienced serious (medically significant) unexpected event of paralysis, that occurred approximately 5 months after the 2nd dose of the mRNA-1273.  Initially, 2 weeks after vaccination, the patient developed weakness in legs which further progressed until collapse and paralysis from neck down which lasted for 5 months. At the time of the report, the patient regained some motion in arms but was still paralyzed from waist down. The patient's relevant medical history is a possible confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.