Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: broke into big sweats/started sweating again; he felt light head; he felt very week; stumbling; started feeling real bad; he could not sleep; had low grade temperature; felt arm soreness; Sickness/been sick the whole week; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sickness/been sick the whole week), GAIT DISTURBANCE (stumbling), FEELING ABNORMAL (started feeling real bad), INSOMNIA (he could not sleep) and ASTHENIA (he felt very week) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:high cholesterol, asthma, high blood pressure.  Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) on 24-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose) on 07-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster) in September 2021 and flu shot. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and flu shot. Concurrent medical conditions included High cholesterol, Asthma and Blood pressure high. Concomitant products included MONTELUKAST, AMLODIPINE, HYDROCHLOROTHIAZIDE, PREDNISONE, COLECALCIFEROL (VITAMIN D3) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 09-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Jan-2023, the patient experienced ILLNESS (Sickness/been sick the whole week) and PAIN IN EXTREMITY (felt arm soreness). On 12-Jan-2023, the patient experienced GAIT DISTURBANCE (stumbling), FEELING ABNORMAL (started feeling real bad), INSOMNIA (he could not sleep) and PYREXIA (had low grade temperature). On 14-Jan-2023, the patient experienced ASTHENIA (he felt very week) and DIZZINESS (he felt light head). On an unknown date, the patient experienced HYPERHIDROSIS (broke into big sweats/started sweating again). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness/been sick the whole week) had not resolved and GAIT DISTURBANCE (stumbling), FEELING ABNORMAL (started feeling real bad), INSOMNIA (he could not sleep), ASTHENIA (he felt very week), HYPERHIDROSIS (broke into big sweats/started sweating again), DIZZINESS (he felt light head), PYREXIA (had low grade temperature) and PAIN IN EXTREMITY (felt arm soreness) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: temperature was normal.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported on 10-Jan-2023 and 11-Jan-2023 patient felt fine and patient felt better on 13-Jan-2023.  It was reported since 16-Jan-2023 patient started feeling a bit better Symptoms are improving but patient still sweats if does anything.   This case was linked to US-MODERNATX, INC.-MOD-2023-697802   Most recent FOLLOW-UP information incorporated above includes: On 16-Jan-2023: Significant Live Follow-up : Relevant Past drug history Updated On 17-Jan-2023: Live Follow-up Significant information include patient information, Reporter information added and updated, event added, relevant past drug history, relevant medical history, batch/lot number, concomitant drug and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697802:Wife case