Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Vomiting
Clinical narrative: crying, body having uncontrolable, spasms,seizures; leg weakness to both my legs from my hips to my knees; "twitching" to my face; chronic pain; weakness; fever 102.6; nausea and vomiting; nausea and vomiting; headache that exacerbated migraines; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (crying, body having uncontrolable, spasms,seizures) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Aspirin), Sulfonamide allergy, Migraine and Asthma. Concomitant products included VALACYCLOVIR [VALACICLOVIR] for Herpes NOS, ATORVASTATIN for High cholesterol, METOPROLOL for Hypertension, AMITRIPTYLINE for Insomnia, TOPIRAMATE for Migraine.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced MIGRAINE (headache that exacerbated migraines), PYREXIA (fever 102.6), NAUSEA (nausea and vomiting) and VOMITING (nausea and vomiting). On 27-Jan-2021, the patient experienced ASTHENIA (weakness). On an unknown date, the patient experienced SEIZURE (crying, body having uncontrolable, spasms,seizures) (seriousness criterion medically significant), MUSCULAR WEAKNESS (leg weakness to both my legs from my hips to my knees), MUSCLE TWITCHING ("twitching" to my face) and PAIN (chronic pain). On 27-Jan-2021, MIGRAINE (headache that exacerbated migraines) had resolved. On 28-Jan-2021, ASTHENIA (weakness), PYREXIA (fever 102.6), NAUSEA (nausea and vomiting) and VOMITING (nausea and vomiting) had resolved. At the time of the report, SEIZURE (crying, body having uncontrolable, spasms,seizures), MUSCULAR WEAKNESS (leg weakness to both my legs from my hips to my knees), MUSCLE TWITCHING ("twitching" to my face) and PAIN (chronic pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Magnetic resonance imaging: negative (Negative) Negative. On 27-May-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 27-May-2021, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Computerised tomogram: negative (Negative) Negative.         Treatment medications was not reported.  The action taken with mRNA-1273 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JUN-2021 - New events added (Case upgraded to serious); 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.