Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis, Nasal disorder, SARS-CoV-2 test, Thrombosis
Clinical narrative: She became totally deaf in the left ear; had partial loss of hearing in right ear; Lost left nostril function for one month; diagnosed with Blood Clot in her right calf; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (diagnosed with Blood Clot in her right calf) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer (Breast cancer on the left breast 25 years ago.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced THROMBOSIS (diagnosed with Blood Clot in her right calf) (seriousness criterion medically significant) and NASAL DISORDER (Lost left nostril function for one month). On 06-Nov-2021, the patient experienced DEAFNESS UNILATERAL (She became totally deaf in the left ear) and HYPOACUSIS (had partial loss of hearing in right ear). On 30-Aug-2021, NASAL DISORDER (Lost left nostril function for one month) had resolved. At the time of the report, THROMBOSIS (diagnosed with Blood Clot in her right calf) had not resolved and DEAFNESS UNILATERAL (She became totally deaf in the left ear) and HYPOACUSIS (had partial loss of hearing in right ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) never had positive covid test.         No concomitant medications were reported.  Patient has received 2 doses of Moderna COVID-19 vaccine. Patient stated that at the time of vaccination she was 78 years old. Patient took first dose on 05MAR2021. Patient did not notice any adverse reactions after the first dose. Patient received second dose on 02APR2021. On 31July2021 patient was diagnosed with Blood Clot in her right calf. On 31July2021, patient also lost left nostril function (could not breath and snored) for 1 month. The left nostril function was restored after 1 month. Patient never had positive COVID test.  Patient was still being treated for blood clot. MD Injected Steroids in the ear drum and it did not help.  Patient received steroids injection in the ear drum and blood clot treatment was still going.  Company comment:  Very little information is available and is disjointed. This spontaneous case concerns a 78-year-old female with no relevant medical history who experienced the serious (medically significant) event of thrombus 3 months 30 days after the second dose of mRNA-1273. Testing and type of treatment not reported and event is ongoing with continuing treatment that is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Very little information is available and is disjointed. This spontaneous case concerns a 78-year-old female with no relevant medical history who experienced the serious (medically significant) event of thrombus 3 months 30 days after the second dose of mRNA-1273. Testing and type of treatment not reported and event is ongoing with continuing treatment that is unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.