Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Loss of smell; Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     It was reported that the patient did not have any allergies to medication, food and other products, and also patient did not have any acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Cancer since 2015, Anxiety, Sleep disorder and Heart disease, unspecified (Heart health). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Heart disease, unspecified, ESZOPICLONE (LUNESTA) for Sleep disorder.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced AGEUSIA (Loss of taste). On an unknown date, the patient experienced ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment was not reported. patient's date of birth was given  Company Comment: This spontaneous case concerns  a 63 year old female patient with relevant medical history of Cancer and heart disease , who experienced non-serious , unexpected, AESI events of Anosmia and Ageusia which occurred 3 days post vaccination with the 1st dose of mRNA-1273 vaccine.  It was reported that this patient made an  outpatient visit regarding the event however no further details was reported like treatment and diagnostic work up ,. However after a year this patient was diagnosed with Covid 19  treated with Nirmatrelvir plus ritonavir ( Paxlovid)  for 5 days  at an unknown dose and frequency.  She reported that the previously reported events of anosmia and ageusia (  experienced  March 2021 )   which she had after vaccination with the first dose of the mRNA-1273 vaccine  resolved during treatment with Paxlovid   but reccurred post treatment  .The age of this patient plus the history of heart disease and Cancer may be considered as confounders for the events . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-557746 (Patient Link).; Sender's Comments: This spontaneous case concerns  a 63 year old female patient with relevant medical history of Cancer and heart disease , who experienced non-serious , unexpected, AESI events of Anosmia and Ageusia which occurred 3 days post vaccination with the 1st dose of mRNA-1273 vaccine.  It was reported that this patient made an  outpatient visit regarding the event however no further details was reported like treatment and diagnostic work up ,. However after a year this patient was diagnosed with Covid 19  treated with Nirmatrelvir plus ritonavir ( Paxlovid)  for 5 days  at an unknown dose and frequency.  She reported that the previously reported events of anosmia and ageusia (  experienced  March 2021 )   which she had after vaccination with the first dose of the mRNA-1273 vaccine  resolved during treatment with Paxlovid   but reccurred post treatment  .The age of this patient plus the history of heart disease and Cancer may be considered as confounders for the events . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.