Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, COVID-19, Drug ineffective
Clinical narrative: Altered level of consciousness; Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CORONAVIRUS TEST POSITIVE (tested positive for Covid-19 he took both the nasal swab test and the PCR). On an unknown date, the patient experienced ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness) (seriousness criterion medically significant), RHINORRHOEA (Runny nose), HEAD DISCOMFORT (Extreme Head Pressure/Cranial Pressure), DYSPNOEA (Shortness of breath), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (An absolute terrible head throbbing./Headache), PYREXIA (Fever) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (Altered level of consciousness), CORONAVIRUS TEST POSITIVE (tested positive for Covid-19 he took both the nasal swab test and the PCR), RHINORRHOEA (Runny nose), HEAD DISCOMFORT (Extreme Head Pressure/Cranial Pressure), DYSPNOEA (Shortness of breath), COUGH (Cough), NASAL CONGESTION (Nasal congestion), HEADACHE (An absolute terrible head throbbing./Headache), PYREXIA (Fever) and MYALGIA (Muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, COVID-19: positive (Positive) Positive. On an unknown date, Blood alkaline phosphatase: 36 (Low) Alkaline phosphatase decreased.. On an unknown date, Blood creatinine: 1.3 (High) Creatinine increased.. On an unknown date, Body temperature: 101.5 fahrenheit (High) Body temperature increased.. On an unknown date, Haematocrit: 39.3 (Low) Hematocrit decreased. On an unknown date, Haemoglobin: 13.2 (Low) Hemoglobin decreased.. On an unknown date, Lymphocyte count: 46.3 (High) Lymphocytes increased. On an unknown date, Mean platelet volume: 11.5 (High) Mean platelet volume increased.. On an unknown date, Monocyte count: 12.5 (High) Monocytes increased.. On an unknown date, Neutrophil count: 1.77 (Low) Absolute neutrophil count decreased. and 37.1 (Low) Neutrophils decreased.. On an unknown date, Red blood cell count: 4.39 (Low) RBC decreased. On an unknown date, Troponin: abnormal (abnormal) abnormal.         Patient reported that he received nebulizer as a treatment. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant information received on 3-Sep-2021. Lab data, event details, treatment medication were added.; Sender's Comments: This is a case of drug ineffective. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event of altered state of consciousness, a causal relationship cannot be excluded.