Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Deafness, Ill-defined disorder, Tinnitus, Vomiting
Clinical narrative: prednisone worsened her symptoms; Hearing loss; manstasis; Tinnitus; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of METASTASIS (Metastasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PREDNISONE for an unknown indication.    No medical history reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PREDNISONE (unknown route) 40 mg once a day. On 25JAN2021 and she was experiencing hearing loss, tinnitus, menstasis, and vomiting. During the time when her symptoms started happening, she had no idea what was going on. Patient has through three emergency room visits and two hospitalizations because of her symptoms. Her doctor prescribed her medications to treat her vomiting. She reported that prednisone worsened her symptoms.On 26-Jan-2021, the patient experienced ILL-DEFINED DISORDER (Manstasis) (seriousness criteria hospitalization and medically significant), DEAFNESS (Hearing loss) (seriousness criteria hospitalization and medically significant), TINNITUS (Tinnitus) (seriousness criterion hospitalization), and VOMITING (Vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced CONDITION AGGRAVATED (prednisone worsened her symptoms) (seriousness criterion hospitalization). The patient was treated with MECLIZINE [MECLOZINE] for Adverse event, at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at a dose of 1 dosage form; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Adverse event, at a dose of 1 dosage form; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for Adverse event, at a dose of 1 dosage form; LORAZEPAM (ATIVAN) for Adverse event, at a dose of 1 dosage form; Physical therapy for Metastasis; Physical therapy for Deafness; Physical therapy for Tinnitus and Physical therapy (Therapy helping her with her balance) for Vestibular neuronitis. At the time of the report, ILL-DEFINED DISORDER (Manstasis), DEAFNESS (Hearing loss), TINNITUS (Tinnitus), VOMITING (Vomiting), and CONDITION AGGRAVATED (prednisone worsened her symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had through three emergency room visits and two hospitalizations because of her symptoms. The patient stopped taking Ativan because she heard the medication can worsen her symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded. Further information has been requested. Patient medical history may provide alterative justification for the vents occurrence.