Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Magnetic resonance imaging, Migraine, Seizure
Clinical narrative: She couldn't move her right face; Migraines; She couldn't move her left arm; Pain in right face; Anorexic; lost almost 20lbs in last 4 months; Can't sleep at night; Vomiting; Uncontrollable seizures / seizures happen many times a day / atypical seizures; tremor; Had chest pain /there's burning in chest/it feels like heart collapsed or crashed; She was having difficulty breathing / it's hard to breathe sometimes; Couldn't swallow well; Felt weak; Felt like she was having a headache in the front of her head; she had difficulty talking / she can't speak sometimes; Fast heartbeat / a fast heart rate / it feels like my heart collapsed or crashed; Muscle spasms to her right face; Had sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Uncontrollable seizures / seizures happen many times a day / atypical seizures) and FACIAL PARALYSIS (She couldn't move her right face) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE PAIN (Had sore arm). On 09-Jul-2021, the patient experienced FACIAL SPASM (Muscle spasms to her right face). On 15-Jul-2021, the patient experienced SPEECH DISORDER (she had difficulty talking / she can't speak sometimes), HEART RATE INCREASED (Fast heartbeat / a fast heart rate / it feels like my heart collapsed or crashed), ASTHENIA (Felt weak) and HEADACHE (Felt like she was having a headache in the front of her head). On 26-Oct-2021, the patient experienced CHEST PAIN (Had chest pain /there's burning in chest/it feels like heart collapsed or crashed), TREMOR (tremor), DYSPNOEA (She was having difficulty breathing / it's hard to breathe sometimes) and DYSPHAGIA (Couldn't swallow well). On 18-Nov-2021, the patient experienced SEIZURE (Uncontrollable seizures / seizures happen many times a day / atypical seizures) (seriousness criterion medically significant), INSOMNIA (Can't sleep at night), WEIGHT DECREASED (lost almost 20lbs in last 4 months) and VOMITING (Vomiting). On an unknown date, the patient experienced FACIAL PARALYSIS (She couldn't move her right face) (seriousness criterion medically significant), MIGRAINE (Migraines), VACCINATION SITE MOVEMENT IMPAIRMENT (She couldn't move her left arm), FACIAL PAIN (Pain in right face) and DECREASED APPETITE (Anorexic). The patient was treated with LORAZEPAM for Seizures, at a dose of 1 mg every eight hours and DULOXETINE for Pain in face and Pain in arm, at a dose of 60 mg. At the time of the report, SEIZURE (Uncontrollable seizures / seizures happen many times a day / atypical seizures), FACIAL PARALYSIS (She couldn't move her right face), CHEST PAIN (Had chest pain /there's burning in chest/it feels like heart collapsed or crashed), SPEECH DISORDER (she had difficulty talking / she can't speak sometimes), TREMOR (tremor), MIGRAINE (Migraines), VACCINATION SITE MOVEMENT IMPAIRMENT (She couldn't move her left arm), FACIAL SPASM (Muscle spasms to her right face), INSOMNIA (Can't sleep at night), FACIAL PAIN (Pain in right face), HEART RATE INCREASED (Fast heartbeat / a fast heart rate / it feels like my heart collapsed or crashed), DYSPNOEA (She was having difficulty breathing / it's hard to breathe sometimes), DYSPHAGIA (Couldn't swallow well), ASTHENIA (Felt weak), DECREASED APPETITE (Anorexic), WEIGHT DECREASED (lost almost 20lbs in last 4 months), VACCINATION SITE PAIN (Had sore arm), HEADACHE (Felt like she was having a headache in the front of her head) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: diagnosed with headache (abnormal) Diagnosed with headache. On an unknown date, Magnetic resonance imaging: there were no findings (normal) There were no findings..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient visited neurologist and was diagnosed with atypical seizures and seizures seem to get worse every month.  Company comment: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced serious unexpected events of seizure and serious expected facial paralysis. The events started occurring approximately 9 days after the first dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to lack of information on the second dose and unknown outcome of the events, no rechallenge was done and thus, recurrence was not applicable .  The benefit-risk relationship of product is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37-year-old female patient with no relevant medical history who experienced serious unexpected events of seizure and serious expected facial paralysis. The events started occurring approximately 9 days after the first dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since due to lack of information on the second dose and unknown outcome of the events, no rechallenge was done and thus, recurrence was not applicable .  The benefit-risk relationship of product is not affected by this report