Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inner ear disorder, Mass, Muscle spasms, Nausea, Pharyngeal swelling
Clinical narrative: Throat swelling; Inner ear swelling; inner ear swelling; Left ear imbalance when walking; Nausea; Severe headache; 103ºF - 104ºF Fever; Joints on fire; Big mass well on right; Convulsion; Uncontrollable shaking; Severe muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Convulsion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939966 or 939906, 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Immunocompromised and Cancer. Concomitant products included EXEMESTANE for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced SEIZURE (Convulsion) (seriousness criterion medically significant), TREMOR (Uncontrollable shaking), MUSCLE SPASMS (Severe muscle cramps), MASS (Big mass well on right), NAUSEA (Nausea), HEADACHE (Severe headache), PYREXIA (103ºF - 104ºF Fever) and ARTHRALGIA (Joints on fire). On 04-Sep-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling), EAR SWELLING (Inner ear swelling) and BALANCE DISORDER (Left ear imbalance when walking). 04-Sep-2021, the patient experienced INNER EAR DISORDER (inner ear swelling). At the time of the report, SEIZURE (Convulsion), TREMOR (Uncontrollable shaking), MUSCLE SPASMS (Severe muscle cramps), PHARYNGEAL SWELLING (Throat swelling), EAR SWELLING (Inner ear swelling), INNER EAR DISORDER (inner ear swelling), MASS (Big mass well on right), BALANCE DISORDER (Left ear imbalance when walking), NAUSEA (Nausea), HEADACHE (Severe headache), PYREXIA (103ºF - 104ºF Fever) and ARTHRALGIA (Joints on fire) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103ºf - 104ºf (High) 103ºF - 104ºF.         Treatment information was not provided.  Company Comment:  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. The events "Uncontrollable shaking", and "Muscle spasms" could also be a manifestation of the event "Convulsion". The event "Balance disorder" may also be due o the event "Inner ear swelling".   This case was linked to MOD-2021-308340 (Patient Link).; 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. The events "Uncontrollable shaking", and "Muscle spasms" could also be a manifestation of the event "Convulsion". The event "Balance disorder" may also be due o the event "Inner ear swelling".