Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: little bit of pain in the arm; he has had no smell or taste; he has had no smell or taste; 1st dose on 19-May-2921 and 2nd dose on 24-June-2021; This spontaneous case was reported by a patient and describes the occurrence of ANOSMIA (he has had no smell or taste), AGEUSIA (he has had no smell or taste), PAIN IN EXTREMITY (little bit of pain in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19-May-2921 and 2nd dose on 24-June-2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 004C21A and 054C21A) for COVID-19 prophylaxis.     It was reported that the patient had no allergies and not diagnosed with COVID-19. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (he had received a different COVID-19 vaccine in another country). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE. Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN for Type 2 diabetes mellitus.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19-May-2921 and 2nd dose on 24-June-2021). In March 2023, the patient experienced ANOSMIA (he has had no smell or taste) and AGEUSIA (he has had no smell or taste). On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of pain in the arm). At the time of the report, ANOSMIA (he has had no smell or taste) and AGEUSIA (he has had no smell or taste) had not resolved, PAIN IN EXTREMITY (little bit of pain in the arm) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 19-May-2921 and 2nd dose on 24-June-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient did not had any major side effects from the vaccine at all. The patient had a little bit of pain in the arm, but it was not too bad and did not last long. However, for approximately a month now, the patient had no smell or taste. The patient does not remember the exact date the symptoms started, but reported that it was around the end of March 2023. The patient that heard that the sense of smell and taste may return in 3 to 4 months.  No treatment medication was reported. Company comment This spontaneous case concerns a 61-year-old male patient with relevant medical history of Type 2 diabetes mellitus, who experienced the non-serious, unexpected AESI of anosmia and ageusia, which occurred approximately 1 year after the third dose of mRNA-1273. The patient received the 2 primary doses of mRNA-1273 with an Inappropriate schedule of product administration. It was reported that the patient did not have any major side effects from the vaccine. He had a little bit of pain in the arm, but it was not too bad and did not last long. However, for approximately a month now, the patient had no smell or taste. He did not remember the exact date the symptoms started but reported that it was around the end of March 2023, that is, almost 1 year after the last dose of mRNA-1273. Since there is lack of temporal relationship between ageusia and anosmia with the vaccine, the causality was assessed as not related. No further clinical information was provided for medical review. The medical history of Type 2 diabetes mellitus could be associated with anosmia and ageusia. The benefit-risk relationship of mRNA-1273 is not affected by this report.