Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Micturition urgency, Muscular weakness, Paralysis, Vision blurred
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PARALYSIS (paralysis/ I was aware of everything happening but could not communicate), VISION BLURRED (Vision blurriness), MUSCULAR WEAKNESS (Inability to use any limb including neck), APHASIA (Inability to talk) and ASTHENIA (Very weak) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A20A and 042?21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bipolar disorder since 1985, Penicillin allergy and Drug allergy (Bactrim, Baclofen). Concomitant products included CLONAZEPAM (KLONOPIN) for Anxiety, TRAZODONE for Depression, LAMOTRIGINE (LAMICTAL) for Mood disorder, QUETIAPINE FUMARATE (SEROQUEL SR) for Psychosis.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PARALYSIS (paralysis/ I was aware of everything happening but could not communicate) and ASTHENIA (Very weak). 20-Apr-2021, the patient experienced VISION BLURRED (Vision blurriness), MUSCULAR WEAKNESS (Inability to use any limb including neck), APHASIA (Inability to talk), GRUNTING (unable to grunt), MICTURITION URGENCY (Sudden urge to urinate) and DYSPHAGIA (Unable to swallow liquids). On 21-Apr-2021, the patient experienced ASTHENIA (Weak) and HEADACHE (Very painful headache). On 22-Apr-2021, the patient experienced FATIGUE (Extremelty fatigued). On 24-Apr-2021, PARALYSIS (paralysis/ I was aware of everything happening but could not communicate) had resolved. At the time of the report, VISION BLURRED (Vision blurriness), MUSCULAR WEAKNESS (Inability to use any limb including neck), APHASIA (Inability to talk), ASTHENIA (Very weak), ASTHENIA (Weak), GRUNTING (unable to grunt), MICTURITION URGENCY (Sudden urge to urinate), DYSPHAGIA (Unable to swallow liquids), HEADACHE (Very painful headache) and FATIGUE (Extremelty fatigued) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PARALYSIS (paralysis/ I was aware of everything happening but could not communicate) to be possibly related. No further causality assessments were provided for VISION BLURRED (Vision blurriness), MUSCULAR WEAKNESS (Inability to use any limb including neck), APHASIA (Inability to talk), ASTHENIA (Very weak), ASTHENIA (Weak), GRUNTING (unable to grunt), MICTURITION URGENCY (Sudden urge to urinate), DYSPHAGIA (Unable to swallow liquids), HEADACHE (Very painful headache) and FATIGUE (Extremelty fatigued).    Treatment information was unknown. Patient's vitals were normal. Action taken with mRNA-1273 in response to the drug was not applicable.  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.   This case was linked to MOD-2021-075017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up received on 18-JUN-2021 contain non significant 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 events, a causal relationship cannot be excluded.