Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Fall, Fatigue, Feeling abnormal
Clinical narrative: ear pain (throbing) /eye sockets hurt.; left eye jumps & twitches; Blurry vision; Eye fatigue; Depth perception problem; Head feels foggy. At times, I don't think or talk clearly; Vestibular Neuritis; Vomited three times; Nausea; Chills; get dizzy from moving my head, walking, bending, watching things moving, etc/Not steady on my feet and have to hold on to things because of dizziness; Room was spinning, left and right vertigo/ Benign paroxysmal vertigo; Fell over once; Lethargic; Headache; Fatigued; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (get dizzy from moving my head, walking, bending, watching things moving, etc/Not steady on my feet and have to hold on to things because of dizziness), VERTIGO (Room was spinning, left and right vertigo/ Benign paroxysmal vertigo), FALL (Fell over once), LETHARGY (Lethargic) and ALTERED VISUAL DEPTH PERCEPTION (Depth perception problem) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation on 18-Jun-2016. Concurrent medical conditions included Allergic reaction to antibiotics (Cephalexin 250mg and Clindamycin 150mg - Rash). Concomitant products included APIXABAN (ELIQUIS) from 20-Jun-2016 to an unknown date, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) from 20-Jun-2016 to an unknown date, ATORVASTATIN from 20-Jun-2016 to an unknown date and MULTIVITAMIN [VITAMINS NOS] from 20-Jan-1980 to an unknown date for an unknown indication.    On 18-Feb-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced LETHARGY (Lethargic), HEADACHE (Headache) and FATIGUE (Fatigued). On 20-Feb-2021, the patient experienced FALL (Fell over once). On 20-Feb-2021 at 3:00 AM, the patient experienced VERTIGO (Room was spinning, left and right vertigo/ Benign paroxysmal vertigo). On 20-Feb-2021 at 7:00 AM, the patient experienced DIZZINESS (get dizzy from moving my head, walking, bending, watching things moving, etc/Not steady on my feet and have to hold on to things because of dizziness) and VOMITING (Vomited three times). 20-Feb-2021 at 7:00 AM, the patient experienced CHILLS (Chills) and NAUSEA (Nausea). On 29-Apr-2021, the patient experienced VESTIBULAR NEURONITIS (Vestibular Neuritis). On an unknown date, the patient experienced ALTERED VISUAL DEPTH PERCEPTION (Depth perception problem), FEELING ABNORMAL (Head feels foggy. At times, I don't think or talk clearly), EAR PAIN (ear pain (throbing) /eye sockets hurt.), BLEPHAROSPASM (left eye jumps & twitches), VISION BLURRED (Blurry vision) and ASTHENOPIA (Eye fatigue). The patient was treated with MECLIZINE HCL on 21-Feb-2021 for Dizziness, at a dose of 12.5 milligram; ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) from 20-Feb-2021 to 21-Feb-2021 for Nausea, at a dose of 4 milligram and Manual therapy (unspecified therapy) for Vestibular neuronitis. On 28-Mar-2021, VERTIGO (Room was spinning, left and right vertigo/ Benign paroxysmal vertigo) had resolved. At the time of the report, DIZZINESS (get dizzy from moving my head, walking, bending, watching things moving, etc/Not steady on my feet and have to hold on to things because of dizziness), CHILLS (Chills), VOMITING (Vomited three times) and NAUSEA (Nausea) had not resolved and FALL (Fell over once), LETHARGY (Lethargic), ALTERED VISUAL DEPTH PERCEPTION (Depth perception problem), FEELING ABNORMAL (Head feels foggy. At times, I don't think or talk clearly), VESTIBULAR NEURONITIS (Vestibular Neuritis), EAR PAIN (ear pain (throbing) /eye sockets hurt.), BLEPHAROSPASM (left eye jumps & twitches), VISION BLURRED (Blurry vision), ASTHENOPIA (Eye fatigue), HEADACHE (Headache) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Computerised tomogram head: abnormal (abnormal) Unremarkable CT brain for acute hemorrhage, hydrocephalus, chronic subdural or parenchymal edema. On 04-May-2021, Magnetic resonance imaging head: abnormal (abnormal) Unremarkable for acute hemorrhage, hydrocephalus, chronic subdural or parenchymal edema..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DIZZINESS (get dizzy from moving my head, walking, bending, watching things moving, etc/Not steady on my feet and have to hold on to things because of dizziness), CHILLS (Chills), VOMITING (Vomited three times) and NAUSEA (Nausea) to be possibly related. No further causality assessments were provided for VERTIGO (Room was spinning, left and right vertigo/ Benign paroxysmal vertigo), FALL (Fell over once), LETHARGY (Lethargic), ALTERED VISUAL DEPTH PERCEPTION (Depth perception problem), FEELING ABNORMAL (Head feels foggy. At times, I don't think or talk clearly), VESTIBULAR NEURONITIS (Vestibular Neuritis), EAR PAIN (ear pain (throbing) /eye sockets hurt.), BLEPHAROSPASM (left eye jumps & twitches), VISION BLURRED (Blurry vision), ASTHENOPIA (Eye fatigue), HEADACHE (Headache) and FATIGUE (Fatigued).    Patient had ECG performed with interpretation, but no result was provided. Patient reported receiving an unspecified ongoing therapy for vestibular neuritis since 06 May 2021.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Additional information received on 11-MAR-2021 include contact information of reporter and adverse events information was updated. On 09-May-2021: Additional information updated include adverse events information.It also contains updated patient history and treatment medications.Reporter information was also added On 13-Jul-2021: Patient demographics were updated. Labs, treatment medication start and stop dates were updated. New events were added and existing event end date was updated.