Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Lethargy, Loss of personal independence in daily activities, Ocular discomfort, Tinnitus
Clinical narrative: Memory loss; Pressure in my head and right ear (not painful); Pressure in my head and right ear (not painful); Ringing in both ears; could not walk; unable to drive car; pressure behind my eyes and right ear; Lethargy; Constant lightheadedness with dizzy spells/severe dizziness; Brain fog/suspects problem in in brain-communication between brain and nerves controlling balance is interrupted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Constant lightheadedness with dizzy spells/severe dizziness), FEELING ABNORMAL (Brain fog/suspects problem in in brain-communication between brain and nerves controlling balance is interrupted), AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)) and EAR DISCOMFORT (Pressure in my head and right ear (not painful)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lisinopril) and Blood pressure high (Under control with medication). Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Acid reflux (oesophageal), BUSPIRONE for Anxiety, LOSARTAN for Hypertension, MONASCUS PURPUREUS (RED YEAST RICE) and MULTIVITAMIN & MINERAL for Supplementation therapy.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 100 microgram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (Constant lightheadedness with dizzy spells/severe dizziness) and FEELING ABNORMAL (Brain fog/suspects problem in in brain-communication between brain and nerves controlling balance is interrupted). On an unknown date, the patient experienced AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)), TINNITUS (Ringing in both ears), GAIT INABILITY (could not walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to drive car), OCULAR DISCOMFORT (pressure behind my eyes and right ear) and LETHARGY (Lethargy). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Sensation of pressure in ear and Ringing in ears, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Ear discomfort and Ringing in ears, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Constant lightheadedness with dizzy spells/severe dizziness) and FEELING ABNORMAL (Brain fog/suspects problem in in brain-communication between brain and nerves controlling balance is interrupted) had not resolved and AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)), TINNITUS (Ringing in both ears), GAIT INABILITY (could not walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to drive car), OCULAR DISCOMFORT (pressure behind my eyes and right ear) and LETHARGY (Lethargy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not get relief after treatment. 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up received on 23-09-2021 and event and patient demographics  and concomitant medications was added.; 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.