Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Restlessness, Tinnitus
Clinical narrative: Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane; Typical Flu like symptoms; Cold sweats; Body aches; Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little; it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general; Can't rest; I can't hardly function; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little), TINNITUS (Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane), IMPAIRED WORK ABILITY (it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general), RESTLESSNESS (Can't rest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't hardly function) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced IMPAIRED WORK ABILITY (it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general), RESTLESSNESS (Can't rest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't hardly function). On 16-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little). On 17-Oct-2021, the patient experienced TINNITUS (Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane), INFLUENZA LIKE ILLNESS (Typical Flu like symptoms), COLD SWEAT (Cold sweats) and MYALGIA (Body aches). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, INSOMNIA (Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little), TINNITUS (Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane), IMPAIRED WORK ABILITY (it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general), RESTLESSNESS (Can't rest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't hardly function) had not resolved and INFLUENZA LIKE ILLNESS (Typical Flu like symptoms), COLD SWEAT (Cold sweats) and MYALGIA (Body aches) was resolving.            No concomitant medication was reported. Patient reported  ringing in ears has just gotten worse ha s driving him insane. The patient also stated that he is starting to feel better but stated that he can't sleep, can't rest and is sleep deprived for days.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-oct-2021 contains significant information events were added. Description to be coded is changed to MedDRA terms