Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Ear discomfort, Electronystagmogram, Fatigue
Clinical narrative: Covid; Body Aches; fever 104-105 degrees; Fatigue; headache; Severe dizziness, vertigo, vomiting, dizziness lasted. Got brain MRI to role at stroke  ok. Saw ENT  diagnosed with vestibular neuritis; This spontaneous case was reported by an other health care professional and describes the occurrence of VESTIBULAR NEURONITIS (Severe dizziness, vertigo, vomiting, dizziness lasted. Got brain MRI to role at stroke  ok. Saw ENT  diagnosed with vestibular neuritis) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (EN6207, anatomical site of injection: arm) on 12-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (EW0151 and anatomical site of injection: arm) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Pre-diabetic, Obesity, Allergy, Mast cell activation syndrome (Mild case of Mast Cell Activator Syndrome (MCAS)), Hypothyroidism and Sleep disorder. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Allergy, THYROID (ARMOUR THYROID) for Hypothyroidism, MELATONIN for Sleep disorder, UBIDECARENONE (COQ10 [UBIDECARENONE]).    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Spikevax), the patient experienced VESTIBULAR NEURONITIS (Severe dizziness, vertigo, vomiting, dizziness lasted. Got brain MRI to role at stroke  ok. Saw ENT  diagnosed with vestibular neuritis) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (Covid), MYALGIA (Body Aches), PYREXIA (fever 104-105 degrees), FATIGUE (Fatigue) and HEADACHE (headache). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-Jul-2022 to 21-Jul-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, VESTIBULAR NEURONITIS (Severe dizziness, vertigo, vomiting, dizziness lasted. Got brain MRI to role at stroke  ok. Saw ENT  diagnosed with vestibular neuritis), COVID-19 (Covid), MYALGIA (Body Aches), PYREXIA (fever 104-105 degrees), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2022, Magnetic resonance imaging head: Ok. On 15-Mar-2022, Ear discomfort: Ok. In April 2022, Electronystagmogram: Vestibular neuritis. On an unknown date, Body temperature: 104-105 degrees. On an unknown date, SARS-CoV-2 test: During the weeks of 20-Dec-2021 to 15-Jan-2022, patient had numerous Rapid and PNR Covid tests due to the holidays-making sure if he was Covid free. All the tests were negative.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered VESTIBULAR NEURONITIS (Severe dizziness, vertigo, vomiting, dizziness lasted. Got brain MRI to role at stroke  ok. Saw ENT  diagnosed with vestibular neuritis) to be related. No further causality assessments were provided for COVID-19 (Covid), MYALGIA (Body Aches), PYREXIA (fever 104-105 degrees), FATIGUE (Fatigue) and HEADACHE (headache).    Had Moderna booster, severe reactions, fever 104-105 degrees, body aches, fatigue, headache. Bedridden for 2-3 days.  ENT said vestibular neuritis likely caused from Moderna Booster.  The patient took the full course of Paxlovid and then may Covid come back with fever, cough, body aches, fatigue, dizziness. It only improved patient's symptoms while taking pills.  Company Comment: This is an spontaneous case concerning a female patient of an unknown age with medical history of Previously administered products included for Product used for unknown indication: PFIZER BIONTECH (2 doses), Concurrent medical conditions included Pre-diabetic, Obesity, Allergy, Mast cell activation syndrome (Mild case of Mast Cell Activator Syndrome (MCAS)), Hypothyroidism and Sleep disorder; Concomitant products included CETIRIZINE, ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE, THYROID (ARMOUR THYROID), MELATONIN, COQ10  who experienced  the seriousness criteria medically significant event of Vestibular neuronitis, the unexpected event of Covid-19 and other expected events 27 days after 3rd. dose of mRNA-1273 vaccine. As the patient received doses of Pfizer vaccine; "interchange of vaccine products" and "revaccination with different Covid-19 vaccine" were noted in this case. In April 2022, Electronystagmogram diagnosticated Vestibular neuritis. The patient was treated with full course of PAXLOVID from 17 to 21-Jul-2022 and then Covid come back with the same symptoms. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.