Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Bedridden, Decreased appetite, Diarrhoea
Clinical narrative: bedridden; Did not have good balance; Diarrhea; Loss of appetite; Nausea; headache migraine; Dizziness; Head heaviness; Feeling Uncomfortable; Uneasy feeling, Felt foggy; Heart Palpitations; can't even move; can't walk; Feeling stomach upset; Sore Arm; This spontaneous case was reported by a dentist and describes the occurrence of HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), BALANCE DISORDER (Did not have good balance), PALPITATIONS (Heart Palpitations) and DIZZINESS (Dizziness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Enlarged prostate and GERD. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for Enlarged prostate, OMEPRAZOLE for GERD.   On 12-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PALPITATIONS (Heart Palpitations) and FEELING ABNORMAL (Uneasy feeling, Felt foggy). In January 2021, the patient experienced HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), ABDOMINAL DISCOMFORT (Feeling stomach upset) and VACCINATION SITE PAIN (Sore Arm). On 20-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEAD DISCOMFORT (Head heaviness), DISCOMFORT (Feeling Uncomfortable) and NAUSEA (Nausea). 20-Jan-2021, the patient experienced MIGRAINE (headache migraine). On 23-Jan-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and DIARRHOEA (Diarrhea). On 27-Jan-2021, the patient experienced BALANCE DISORDER (Did not have good balance). On an unknown date, the patient experienced BEDRIDDEN (bedridden). At the time of the report, HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), BALANCE DISORDER (Did not have good balance), PALPITATIONS (Heart Palpitations), DIZZINESS (Dizziness), FEELING ABNORMAL (Uneasy feeling, Felt foggy), ABDOMINAL DISCOMFORT (Feeling stomach upset), DISCOMFORT (Feeling Uncomfortable), DECREASED APPETITE (Loss of appetite), BEDRIDDEN (bedridden), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Sore Arm) outcome was unknown and HEAD DISCOMFORT (Head heaviness), MIGRAINE (headache migraine) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HEAD DISCOMFORT (Head heaviness), MIGRAINE (headache migraine) and NAUSEA (Nausea) to have an unknown relationship. No further causality assessments were provided for HYPOKINESIA (can't even move), GAIT INABILITY (can't walk), BALANCE DISORDER (Did not have good balance), PALPITATIONS (Heart Palpitations), DIZZINESS (Dizziness), FEELING ABNORMAL (Uneasy feeling, Felt foggy), ABDOMINAL DISCOMFORT (Feeling stomach upset), DISCOMFORT (Feeling Uncomfortable), DECREASED APPETITE (Loss of appetite), BEDRIDDEN (bedridden), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Sore Arm).    Patient received treatment of Tylenol, Advil for heavy head, Motrin/APAP, Meclizine for head problem and fogginess, unspecified medication for migraine. Patient was also prescribed Zoloft for unspecified condition.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient information, suspect product details,concomitant medications, outcome of the events, linking term for headache migraine updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.