Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Hypersensitivity, Vertigo
Clinical narrative: COVID-19; Allergic Reaction; vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (vertigo) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) 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 vaccine (Dose 1, intramuscular route, After 1 day patient had throat closing feeling and took Claritin 10 mg and symptoms resolved.) on 18-Dec-2020, Pfizer vaccine (Dose 1, intramuscular route, After 1 day patient had vomiting and took Claritin 10 mg and symptoms resolved.) on 18-Dec-2020, Pfizer vaccine (Dose 2, intramuscular route, After 15 minutes of vaccination patient had fainted and patient felt better after taking Claritin.) on 08-Jan-2021, Pfizer vaccine (Dose 2, intramuscular route, After 15 minutes of vaccination patient had body ache, myalgia that lasted 2 days.) on 08-Jan-2021, Pfizer vaccine (Dose 2, intramuscular route, After 15 minutes of vaccination patient had vertigo.) on 08-Jan-2021, Pfizer vaccine (Dose 2, intramuscular route, After 15 minutes of vaccination patient had throat closing feeling and patient felt better after taking Claritin.) on 08-Jan-2021, Pfizer vaccine (Dose 2, intramuscular route, After 15 minutes of vaccination patient had blood pressure high and patient felt better after taking Claritin.) on 08-Jan-2021, Pfizer vaccine (Dose 3, intramuscular route, patient took Claritin before taking this vaccine and had no adverse effect or no throat closing feeling.) on 21-Aug-2021 and Pfizer Vaccine (Dose 4); for Throat tightness: Claritin (Patient took after first dose and second dose orally and prior to taking third dose also.); for Vertigo: Ginger root capsule (550 mg capsule and up to 4 per day). Past adverse reactions to the above products included Blood pressure high with Pfizer vaccine; Faint with Pfizer vaccine; Laryngospasm with Pfizer vaccine and Pfizer vaccine; Myalgia with Pfizer vaccine; No adverse effect with Claritin, Ginger root capsule, Pfizer Vaccine and Pfizer vaccine; Vertigo with Pfizer vaccine; and Vomiting with Pfizer vaccine. Concurrent medical conditions included Wheat allergy (wheat allergy, anaphylactic reaction.), Asthma (ASTHMA), Non-smoker (non-smoker), Hypothyroidism (Hypothyroid), Migraine (Migraines), Osteoporosis (Osteoporosis), Psoriasis (Psoriasis), Allergic rhinitis (Allergic Rhinitis), Irritable bowel syndrome (IBS) and Grass allergy (rye allergy, anaphylactic reaction). Concomitant products included CLARITHROMYCIN, LANSOPRAZOLE, TINIDAZOLE (CLANTIN) for Allergic rhinitis, FLUTICASONE FUROATE (ARNUITY ELLIPTA) and MONTELUKAST for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, DENOSUMAB (PROLIA) for an unknown indication.    In January 2021, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In April 2021, the patient experienced VERTIGO (vertigo) (seriousness criterion disability). On an unknown date, the patient experienced COVID-19 (COVID-19) and HYPERSENSITIVITY (Allergic Reaction). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, VERTIGO (vertigo) had not resolved, COVID-19 (COVID-19) had resolved and HYPERSENSITIVITY (Allergic Reaction) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was reported that after the administration of the first dose of Pfizer Covid-19 vaccine, patient felt a throat-closing feeling on 19-DEC-2020 and vomiting after one day. The patient took Clantin 10 mg as a treatment medication, and the symptoms were resolved.  After the second dose, patient felt a throat-closing feeling, which started 15 minutes post-vaccination. The patient took Claritin 10 mg as treatment medication and felt better. The next day, patient had headaches, body aches and myalgia, which lasted for two days. After the third dose, patient took Claritin prior to vaccination and had no side effects or throat-closing feeling. Patient went to see neurologist and took Ginger. Patient undergone many diagnostics and remedies.  Company Comment: This is a spontaneous case concerning a female patient of an unknown age with relevant medical history of migraine, who experienced the serious (per disability) unexpected event of vertigo which occurred about three months after a dose of SPIKEVAX COVID-19 VACCINE NOS received as the fifth dose of COVID-19 Vaccination schedule. The medical history of migraine remains a confounder. It was reported that the patient went to see neurologist and took Ginger, undergone many diagnostics and remedies. No further clinical information or diagnostic tests results were disclosed for analysis. The event had not resolved.  The medical history of migraines could remain a confounding risk factor. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.