Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, SARS-CoV-2 antibody test, Sensitive skin, Tinnitus, X-ray
Clinical narrative: Subcutaneous hypersensitivity itching; Auditory hyper-sensitivity; Tinnitus; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Mar-2021 and was forwarded to Moderna on 23-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), SENSITIVE SKIN (Subcutaneous hypersensitivity itching) and HYPERSENSITIVITY (Auditory hyper-sensitivity) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 012120A) for COVID-19 vaccination.     The patient's past medical history included Anxiety depression (in 2020 stopped entirely taking all anti-depressants and anxiety medication), Tinnitus (Prior to the vaccine I had mild tinnitus), Hypersensitivity (Ear infections from childhood had greater silence and virtually no ringing in the ears.), Splenectomy and Pancreatectomy (2/3). Concurrent medical conditions included Lymphedema, Lymphoedema congenital (Patient had been working for many years to diminish episodes) since 22-Feb-1951, Hypothyroidism (2019 - 2020 lowered medication dosage) since 2019, Drug allergy (Allergy to prednisone,), Sulfonamide allergy (Sulfa (sulfonamide antibiotics)), Allergy to metals (Allergy to Knee Joint Prosthetic components: Nickel), Allergy to metals (Allergy to Knee Joint Prosthetic components: Chromium), Allergy to metals (Allergy to Knee Joint Prosthetic components: Cobalt.), Drug allergy (allergy to Naproxen), Drug allergy (allergy to Sulfisoxazole-Phenazopyridine), Drug allergy (allergy to Chlorhexidine Acetate) and Drug allergy (allergy to Ketorolac). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, VITAMINS NOS for Inflammation, Routine health maintenance and Immune system disorder, SILYBUM MARIANUM (MILK THISTLE LIVER TONIC [SILYBUM MARIANUM]) for Liver disorder, FUROSEMIDE (LASIX [FUROSEMIDE]) for Lymphedema congenital, CYANOCOBALAMIN (B12-VITAMIN), COLECALCIFEROL (D3 VITAMIN), ZINGIBER OFFICINALE ROOT (GINGER ROOT [ZINGIBER OFFICINALE ROOT]), ALLIUM SATIVUM (ALLIMAX) and OCIMUM TENUIFLORUM (TULSI [OCIMUM TENUIFLORUM]) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced TINNITUS (Tinnitus) and HYPERSENSITIVITY (Auditory hyper-sensitivity). On 18-Feb-2021 at 12:15 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SENSITIVE SKIN (Subcutaneous hypersensitivity itching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, TINNITUS (Tinnitus), SENSITIVE SKIN (Subcutaneous hypersensitivity itching) and HYPERSENSITIVITY (Auditory hyper-sensitivity) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive (blood containing antibodies for COVID 19 and 3+ variants). On an unknown date, X-ray: result not provided (Inconclusive) Upper cervical X-rays: result not provided.         Both the tinnitus and itching are still active but milder with recurrent spikes periodically that last a typically a few hours. The patient do have periodic issues with the low-frequency vibrations that are very difficult to tolerate.  Treatment information included doing ayurveda and holistic medicine and currently on 12 different herbal supplements.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Contains no new information. On 11-May-2021: Added laboratory data and outcome of the event was updated. On 14-May-2021: Added patient demographics, laboratory data, reporter information, event details, concomitant medication, medical history and suspect dose details updated.