Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pulse abnormal, Seizure, Swelling, Tremor
Clinical narrative: headache; tiredness; Convulsion; Severe chest pain; Breathing problem; Swelling of his whole body; Severe Allergic reaction; significant drop in blood pressure; Shaking and Tremor all over the body; Pain all over the body; exaggerated pulse at 92 bpm; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B214 and 03114211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Malaria (Had 2 types of Malaria.) and Sick child (Sickly as a child). Concurrent medical conditions included Rheumatic fever and Drug allergy (Allergic to sodium Pentathol). Concomitant products included MULTIVITAMINS [VITAMINS NOS], FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASPIRIN [ACETYLSALICYLIC ACID], TRIAMTERENE, HCTZ, ATORVASTATIN, TERAZOSIN and DICLOFENAC SODIUM (FENDER) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), TREMOR (Shaking and Tremor all over the body), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache) and CHILLS (Chills). On an unknown date, the patient experienced HEADACHE (headache) and FATIGUE (tiredness). On 16-Apr-2021, SEIZURE (Convulsion) had resolved. On 17-Apr-2021, TREMOR (Shaking and Tremor all over the body) and CHILLS (Chills) had resolved. At the time of the report, CHEST PAIN (Severe chest pain), DYSPNOEA (Breathing problem), SWELLING (Swelling of his whole body), ALLERGY TO VACCINE (Severe Allergic reaction), BLOOD PRESSURE DECREASED (significant drop in blood pressure), PAIN (Pain all over the body), PULSE ABNORMAL (exaggerated pulse at 92 bpm), MYALGIA (Body ache), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement (120-90 mmHg): low mmHg (Low) 107/65 Significant drop in Blood pressure. On 16-Apr-2021, Heart rate: abnormal (abnormal) Exaggerated pulse at 92 bpm.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Treatment information was not provided.  Action taken with mRNA-1273 in response to events was not applicable.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.