Sex: F
Vaccine: COVID19
Symptoms: Clinically isolated syndrome, Magnetic resonance imaging, Multiple sclerosis, Radiologically isolated syndrome, Spinal cord disorder
Clinical narrative: headaches in waves/lips and chin twitching/pins and needles in limbs/ pins and needles never went away/diagnosed her with Clinically Isolated Syndrome (CIS); lesions on her spine; Its the very beginning of Multiple Sclerosis; headaches in waves/ lips and chin started twitching/pins and needles in limbs /pins and needles never went away/diagnosed with Radiologically Isolated Syndrome (RIS); This spontaneous case was reported by a consumer and describes the occurrence of CLINICALLY ISOLATED SYNDROME (headaches in waves/lips and chin twitching/pins and needles in limbs/ pins and needles never went away/diagnosed her with Clinically Isolated Syndrome (CIS)), SPINAL CORD DISORDER (lesions on her spine) and MULTIPLE SCLEROSIS (Its the very beginning of Multiple Sclerosis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs allergy), Drug allergy (Opioids allergy) and Brain lesion (Brain lesions not caused by Moderna vaccine and were there prior to receiving the Moderna vaccine).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In May 2021, the patient experienced CLINICALLY ISOLATED SYNDROME (headaches in waves/lips and chin twitching/pins and needles in limbs/ pins and needles never went away/diagnosed her with Clinically Isolated Syndrome (CIS)) (seriousness criterion medically significant), SPINAL CORD DISORDER (lesions on her spine) (seriousness criterion medically significant), MULTIPLE SCLEROSIS (Its the very beginning of Multiple Sclerosis) (seriousness criterion medically significant) and RADIOLOGICALLY ISOLATED SYNDROME (headaches in waves/ lips and chin started twitching/pins and needles in limbs /pins and needles never went away/diagnosed with Radiologically Isolated Syndrome (RIS)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at a dose of UNK, qd and IBUPROFEN ongoing since an unknown date at a dose of UNK, qd. At the time of the report, CLINICALLY ISOLATED SYNDROME (headaches in waves/lips and chin twitching/pins and needles in limbs/ pins and needles never went away/diagnosed her with Clinically Isolated Syndrome (CIS)), SPINAL CORD DISORDER (lesions on her spine), MULTIPLE SCLEROSIS (Its the very beginning of Multiple Sclerosis) and RADIOLOGICALLY ISOLATED SYNDROME (headaches in waves/ lips and chin started twitching/pins and needles in limbs /pins and needles never went away/diagnosed with Radiologically Isolated Syndrome (RIS)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Magnetic resonance imaging: old lesions on her brain (abnormal) "old lesions" on her brain and lesions on her spine (abnormal) "check out her spine". Second MRI found lesions on her spine.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant and treatment medication information was reported. The patient reported that couple hours after receiving her first Moderna COVID-19 dose (20-Apr-2021), she started experiencing headaches in waves (occurring approximately every 10 minutes). She stated the headaches lasted for weeks and then resolved. She also reported that her lips and chin started twitching after receiving the first Moderna dose and has been ongoing for the last 10 months. She started experiencing pins and needles in her limbs two weeks after receiving the first Moderna dose. She went to the emergency room (date not provided) and the emergency room neurologist ruled out Guillain-Barre syndrome. She reported the pins and needles are ongoing and "never went away". Her first MRI in May 2021 (exact date unknown). She stated the MRI found "old lesions" on her brain. The HCP that reviewed the results stated that the brain lesions were not caused by the Moderna vaccine and were there prior to receiving the Moderna vaccine. She had a second MRI also later in MAY 2021 (exact date unknown) to "check out her spine". She stated the second MRI found lesions on her spine. She stated the first neurologist diagnosed her with Radiologically Isolated Syndrome (RIS) and not Multiple Sclerosis. Her second neurologist diagnosed her with Clinically Isolated Syndrome (CIS); stating it's "the very beginning of Multiple Sclerosis". Her first doctor mentioned the pins and needles was unrelated to the Moderna vaccines. She stated the second doctor stated the pins and needles was related to getting the Moderna vaccine. Company comment: This is a spontaneous case concerning a female patient of unknown age with a relevant medical history of old brain lesions and family history of multiple sclerosis, who experienced the unexpected, serious (medically significant) events of Clinically isolated syndrome (AESI), Spinal cord disorder and Multiple sclerosis(AESI), unspecified days after receiving the first dose of mRNA-1273 vaccine. The patient experienced intermittent headaches followed by twitching of chin and lips, pins and needles in her limbs. She consulted two neurologists. After ruling out Guillain-Barre syndrome, she was diagnosed with Radiologically Isolated Syndrome and Clinically Isolated Syndrome, stating that it was the initial stage of Multiple sclerosis. Magnetic resonance imaging revealed lesions on the spine. No further information regarding clinical course and management of the events was available from the report. Family history of multiple sclerosis could be a risk factor for the event multiple sclerosis. The benefit-risk relationship of mRNA-1273 in not affected by this report.  This case was linked to MOD-2022-508605, MOD-2022-508700 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with a relevant medical history of old brain lesions and family history of multiple sclerosis, who experienced the unexpected, serious (medically significant) events of Clinically isolated syndrome (AESI), Spinal cord disorder and Multiple sclerosis(AESI), unspecified days after receiving the first dose of mRNA-1273 vaccine. The patient experienced intermittent headaches followed by twitching of chin and lips, pins and needles in her limbs. She consulted two neurologists. After ruling out Guillain-Barre syndrome, she was diagnosed with Radiologically Isolated Syndrome and Clinically Isolated Syndrome, stating that it was the initial stage of Multiple sclerosis. Magnetic resonance imaging revealed lesions on the spine. No further information regarding clinical course and management of the events was available from the report. Family history of multiple sclerosis could be a risk factor for the event multiple sclerosis. The benefit-risk relationship of mRNA-1273 in not affected by this report.