Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Gait disturbance, Guillain-Barre syndrome, Headache, Hemiparesis
Clinical narrative: Side effects are like GBS (Guillain-Barré syndrome); Right side of her body has weakened due to the Moderna vaccine; Forgetful; Sometimes is short of breath; Stumbling; Isn't going to received the second dose; Dizziness; Losing her balance; Lost sense of taste (couldn't taste sour)/food doesn't taste good at all now; Lost 20 lbs. from not eating as much; Headache; hard time thinking; Tingling of right arm/ tingling and numbness in right arm/hands started tingling like "pins and needles"/diagnosed with Paresthesia possibly from the Moderna vaccination; "Hands went kind of numb"/numbness spread up both arms/right side of her body was numb; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Side effects are like GBS (Guillain-Barré syndrome)), HEMIPARESIS (Right side of her body has weakened due to the Moderna vaccine) and MENTAL IMPAIRMENT (hard time thinking) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included INSULIN GLARGINE (LANTUS), THYROID (ARMOUR THYROID), COLECALCIFEROL (VITAMIN D3), VITAMIN B12 NOS, ZINC CHELATE from 12-Jul-2021 to an unknown date and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PARAESTHESIA (Tingling of right arm/ tingling and numbness in right arm/hands started tingling like "pins and needles"/diagnosed with Paresthesia possibly from the Moderna vaccination), HYPOAESTHESIA ("Hands went kind of numb"/numbness spread up both arms/right side of her body was numb), NAUSEA (Nausea) and MENTAL IMPAIRMENT (hard time thinking) (seriousness criterion medically significant). On 26-Apr-2021, the patient experienced DIZZINESS (Dizziness), BALANCE DISORDER (Losing her balance), AGEUSIA (Lost sense of taste (couldn't taste sour)/food doesn't taste good at all now), WEIGHT DECREASED (Lost 20 lbs. from not eating as much) and HEADACHE (Headache). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Side effects are like GBS (Guillain-Barré syndrome)) (seriousness criterion medically significant), HEMIPARESIS (Right side of her body has weakened due to the Moderna vaccine) (seriousness criterion medically significant), MEMORY IMPAIRMENT (Forgetful), DYSPNOEA (Sometimes is short of breath), GAIT DISTURBANCE (Stumbling) and PRODUCT DOSE OMISSION ISSUE (Isn't going to received the second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Side effects are like GBS (Guillain-Barré syndrome)), HEMIPARESIS (Right side of her body has weakened due to the Moderna vaccine), HYPOAESTHESIA ("Hands went kind of numb"/numbness spread up both arms/right side of her body was numb), BALANCE DISORDER (Losing her balance), AGEUSIA (Lost sense of taste (couldn't taste sour)/food doesn't taste good at all now), WEIGHT DECREASED (Lost 20 lbs. from not eating as much), MEMORY IMPAIRMENT (Forgetful), DYSPNOEA (Sometimes is short of breath), GAIT DISTURBANCE (Stumbling) and HEADACHE (Headache) outcome was unknown, DIZZINESS (Dizziness), PARAESTHESIA (Tingling of right arm/ tingling and numbness in right arm/hands started tingling like "pins and needles"/diagnosed with Paresthesia possibly from the Moderna vaccination), NAUSEA (Nausea) and MENTAL IMPAIRMENT (hard time thinking) had not resolved and PRODUCT DOSE OMISSION ISSUE (Isn't going to received the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Magnetic resonance imaging head: stroke was not diagnosed (Inconclusive) stroke was not diagnosed. In 2021, Blood pressure measurement: high (High) Blood pressure increased.. In 2021, Electrocardiogram: normal (normal) Normal; stroke was not diagnosed.. On 18-Jun-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported experiencing events similar to GBS (Guillain-Barre syndrome), however, diagnosis had not yet been medically confirmed. Patient laboratory investigation included, on an unknown date, a visit to emergency room (Blood test, urine analysis, EKG and X-rays).  Results were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up was received on 13-JUL-2021 Contains significant information. Updated Reporter information, patient demographics and suspect drug information. Added, Laboratory investigation, concomitant and treatment medication and  New events information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.