Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: the injection site swelled up, got very hard and ooze fluid for about 10 days; the injection site swelled up, got very hard and ooze fluid for about 10 days; the injection site swelled up, got very hard and ooze fluid for about 10 days; Previous Moderna vaccines 1. 26Feb2021 013A21A 2. 03Apr2021 016B21A; they lost sense of smell and taste and it has not returned; they lost sense of smell and taste and it has not returned; This spontaneous case was reported by a patient and describes the occurrence of ANOSMIA (they lost sense of smell and taste and it has not returned), AGEUSIA (they lost sense of smell and taste and it has not returned), VACCINATION SITE DISCHARGE (the injection site swelled up, got very hard and ooze fluid for about 10 days), VACCINATION SITE SWELLING (the injection site swelled up, got very hard and ooze fluid for about 10 days) and VACCINATION SITE INDURATION (the injection site swelled up, got very hard and ooze fluid for about 10 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 016B21A, 047C21A and 066K21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No relevant medical history or conditions, allergy, concomitant diseases and risk factor.  Concurrent medical conditions included Macular degeneration. Concomitant products included ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]) for Macular degeneration.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previous Moderna vaccines 1. 26Feb2021 013A21A 2. 03Apr2021 016B21A). In 2021, the patient experienced ANOSMIA (they lost sense of smell and taste and it has not returned) and AGEUSIA (they lost sense of smell and taste and it has not returned). In 2022, the patient experienced VACCINATION SITE DISCHARGE (the injection site swelled up, got very hard and ooze fluid for about 10 days), VACCINATION SITE SWELLING (the injection site swelled up, got very hard and ooze fluid for about 10 days) and VACCINATION SITE INDURATION (the injection site swelled up, got very hard and ooze fluid for about 10 days). In 2021, ANOSMIA (they lost sense of smell and taste and it has not returned) and AGEUSIA (they lost sense of smell and taste and it has not returned) had not resolved. In 2022, VACCINATION SITE DISCHARGE (the injection site swelled up, got very hard and ooze fluid for about 10 days), VACCINATION SITE SWELLING (the injection site swelled up, got very hard and ooze fluid for about 10 days) and VACCINATION SITE INDURATION (the injection site swelled up, got very hard and ooze fluid for about 10 days) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Previous Moderna vaccines 1. 26Feb2021 013A21A 2. 03Apr2021 016B21A) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had dose 5 on 14 Oct 2022 with batch number 0575221A.  The patient had age related macular degeneration of the eye. Every couple month they get a shot Avastin in the eye to control the blood vessels.  The patient had Moderna previously and had not been without complications. The first dose gave him the trouble. About 3 or 4 days after, they lost sense of smell and taste, and it was not returned.  After the 4th shot patient had injection site reaction. About 3 to 4 days after the shot, the injection site swelled up, got very hard and ooze fluid for about 10 days. Patient finally went to the doctor, and they gave him some antibiotics. Patient thought it might had been a contaminate needled.; Reporter's Comments: This is a Spontaneous case reported by a patient, concerning a 77-year-old male patient, with no relevant medical history, who experienced the unexpected and non-serious AESIs of Anosmia and Ageusia, which occurred 3-4 days after the first dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.