Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Back pain, Balance disorder, Blood test, Body temperature
Clinical narrative: Pass out feeling / Room turned black for a short period; Lost 4 pounds. Not hungry; feeling depressed; exhausted; Body aches; eyes felt heavy; balance disorder; Bad headache; Difficult to work; Left Ear progressively getting worse, painful; Body shaking /  constantly moving; Dizzy feeling; Left ear fills full at times; Head feels like it is jolting; Extreme dizziness / dizzy; Brain fog / having a feeling of rocking / rocking; Nausea.; Really bad back aches; Fever of about 102; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Pass out feeling / Room turned black for a short period) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD in 2019 and Migraine in 2010. Concurrent medical conditions included Drug allergy and Balance disorder (Confirmed by Otolaryngologist, examining vocal cords.) on 07-Sep-2021. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (ENSKYCE) for Birth control, OMEPRAZOLE for Heartburn, ZONISAMIDE and RIZATRIPTAN for Migraine, METOPROLOL SUCCINATE for Pulse abnormal.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced BACK PAIN (Really bad back aches) and PYREXIA (Fever of about 102). On 03-Apr-2021, the patient experienced DIZZINESS (Extreme dizziness / dizzy) and NAUSEA (Nausea.). 03-Apr-2021, the patient experienced FEELING ABNORMAL (Brain fog / having a feeling of rocking / rocking), EAR DISCOMFORT (Left ear fills full at times) and HEAD DISCOMFORT (Head feels like it is jolting). On 14-Apr-2021, the patient experienced DIZZINESS (Dizzy feeling). On 15-Apr-2021, the patient experienced TREMOR (Body shaking /  constantly moving). On 17-Apr-2021, the patient experienced EAR PAIN (Left Ear progressively getting worse, painful). On 05-May-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficult to work). On 17-Jul-2021, the patient experienced HEADACHE (Bad headache). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Pass out feeling / Room turned black for a short period) (seriousness criterion medically significant), DECREASED APPETITE (Lost 4 pounds. Not hungry), DEPRESSION (feeling depressed), FATIGUE (exhausted), MYALGIA (Body aches), ASTHENOPIA (eyes felt heavy) and BALANCE DISORDER (balance disorder). The patient was treated with MAGNESIUM for Adverse event, at an unspecified dose and frequency; ZINC for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency; FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Ear discomfort, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Ear discomfort, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Pass out feeling / Room turned black for a short period), BACK PAIN (Really bad back aches), EAR DISCOMFORT (Left ear fills full at times), HEAD DISCOMFORT (Head feels like it is jolting), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Difficult to work), TREMOR (Body shaking /  constantly moving), DIZZINESS (Dizzy feeling), DECREASED APPETITE (Lost 4 pounds. Not hungry), DEPRESSION (feeling depressed), EAR PAIN (Left Ear progressively getting worse, painful), PYREXIA (Fever of about 102), NAUSEA (Nausea.), FATIGUE (exhausted), MYALGIA (Body aches), HEADACHE (Bad headache), ASTHENOPIA (eyes felt heavy) and BALANCE DISORDER (balance disorder) outcome was unknown and DIZZINESS (Extreme dizziness / dizzy) and FEELING ABNORMAL (Brain fog / having a feeling of rocking / rocking) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 102 (High) High Body temperature. On 14-May-2021, Vertigo positional: negative (Negative) Negative. On 14-Jun-2021, Blood test: abnormal (abnormal) results: Inflammation. On 23-Jul-2021, Vertigo positional: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter mentioned Chiropractor on 06 May 2021 Lab data on 4-Aug-2021 included MRI of head, no results provided.  On 7-Sep-2021, the patient saw Otolaryngologist for balance disorders. Thorough exam, scope through nose to look at vocal cords. No results provided.  Company Comment: This case concerns a 27-year-old female patient with medical history of migraine and concurrent condition of balance disorder who experienced unexpected serious event of loss of consciousness. Time to onset of the event following administration of Spikevax was not specified. The medical history of migraine and concurrent condition of balance disorder remain confounders.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received contains added patient demographics, medical history, lab investigations, concomitant and treatment medication, event and updated event dates. On 10-Sep-2021: Follow-up received contains added to include reporter's fax number and current condition.; Sender's Comments: This case concerns a 27-year-old female patient with medical history of migraine and concurrent condition of balance disorder who experienced unexpected serious event of loss of consciousness. Time to onset of the event following administration of Spikevax was not specified. The medical history of migraine and concurrent condition of balance disorder remain confounders.