Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Rash, Rash pruritic, Skin swelling
Clinical narrative: hot shower in the evening would make the rash worse/body rash,Its on torso, arms, and hands.; lost some hearing because of the chemo treatment; skin feels bumpy sometimes; itchy rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Dec-2021 and was forwarded to Moderna on 10-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost some hearing because of the chemo treatment) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 016B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy (Patient mentioned that she finished chemo a month and a half ago).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021 at 2:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In 2021, the patient experienced DEAFNESS (lost some hearing because of the chemo treatment) (seriousness criterion medically significant), SKIN SWELLING (skin feels bumpy sometimes) and RASH PRURITIC (itchy rash). On 07-Dec-2021, the patient experienced RASH (hot shower in the evening would make the rash worse/body rash,Its on torso, arms, and hands.). The patient was treated with HYDROCORTISONE on 08-Dec-2021 at a dose of UNK, qhs and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 10-Dec-2021 at an unspecified dose and frequency. At the time of the report, DEAFNESS (lost some hearing because of the chemo treatment) and SKIN SWELLING (skin feels bumpy sometimes) outcome was unknown and RASH PRURITIC (itchy rash) and RASH (hot shower in the evening would make the rash worse/body rash,Its on torso, arms, and hands.) had not resolved.            Concomitant medications was not provided by the reporter.  Patient received the Moderna booster on 07Dec2021 around 2 o'clock in the afternoon. Company Comment: This is a spontaneous case concerns a 70-year-old, female patient with medical history of chemotherapy, who experienced the unexpected, serious (Medically significant) event of deafness. The patient reported that she lost some hearing because of her chemotherapy treatment and mentioned that she finished chemotherapy a month and a half ago of the reporting time. She received a dose of mRNA-1273 vaccine, considered as the third dose of the patient's COVID-19 vaccination schedule after the event occurred. The rechallenge is not applicable. The medical history of chemotherapy remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerns a 70-year-old, female patient with medical history of chemotherapy, who experienced the unexpected, serious (Medically significant) event of deafness. The patient reported that she lost some hearing because of her chemotherapy treatment and mentioned that she finished chemotherapy a month and a half ago of the reporting time. She received a dose of mRNA-1273 vaccine, considered as the third dose of the patient's COVID-19 vaccination schedule after the event occurred. The rechallenge is not applicable. The medical history of chemotherapy remains as a confounder. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.