Sex: F
Vaccine: COVID19
Symptoms: Deafness, Depressed mood, Headache, Inappropriate schedule of product administration, Tinnitus
Clinical narrative: Really bad tinnitus; Headaches so severe I was hospitalized; Lost starting to lose hearing in her right ear 2 days after the second dose/ear just went bad/starting to lose hearing in my left ear; Inappropriate schedule of vaccine administered; I'm pretty sad/I'm pretty depressed/very bummed about this; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Really bad tinnitus), HEADACHE (Headaches so severe I was hospitalized), DEAFNESS (Lost starting to lose hearing in her right ear 2 days after the second dose/ear just went bad/starting to lose hearing in my left ear) and DEPRESSED MOOD (I'm pretty sad/I'm pretty depressed/very bummed about this) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In April 2021, the patient experienced TINNITUS (Really bad tinnitus) (seriousness criteria hospitalization, disability and medically significant), HEADACHE (Headaches so severe I was hospitalized) (seriousness criteria hospitalization, disability and medically significant) and DEPRESSED MOOD (I'm pretty sad/I'm pretty depressed/very bummed about this) (seriousness criteria disability and medically significant). On 16-Apr-2021, the patient experienced DEAFNESS (Lost starting to lose hearing in her right ear 2 days after the second dose/ear just went bad/starting to lose hearing in my left ear) (seriousness criteria disability and medically significant). The patient was hospitalized for 4 days due to HEADACHE and TINNITUS. On 14-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, TINNITUS (Really bad tinnitus), HEADACHE (Headaches so severe I was hospitalized), DEAFNESS (Lost starting to lose hearing in her right ear 2 days after the second dose/ear just went bad/starting to lose hearing in my left ear) and DEPRESSED MOOD (I'm pretty sad/I'm pretty depressed/very bummed about this) had not resolved.            The patient had bad tinnitus and severe headaches, so the patient was hospitalized for four days.  No concomitant product was provided.  No treatment information was provided.  Company comment This is a spontaneous case concerning a female patient of an unknown age with no relevant medical history reported, who experienced the serious, unexpected, according  events of tinnitus, headache, deafness, depressed mood. Inappropriate schedule of product administration was considered an additional event. The event deafness occurred 2 days after the second dose of mRNA-1273 vaccine. The patient felt depressed and experienced Tinnitus and headache, which occurred on an unknown date on the same month after the second dose, they were so severe that the patient required hospitalization for 4 days. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of an unknown age with no relevant medical history reported, who experienced the serious, unexpected, according events of tinnitus, headache, deafness, depressed mood. Inappropriate schedule of product administration was considered an additional event. The event deafness occurred 2 days after the second dose of mRNA-1273 vaccine. The patient felt depressed and experienced Tinnitus and headache, which occurred on an unknown date on the same month after the second dose, they were so severe that the patient required hospitalization for 4 days. The rechallenge is not applicable since the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.