Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, CD4 lymphocytes, Decreased appetite, Inappropriate schedule of product administration, Nausea
Clinical narrative: Lost 20 Lbs; Second Booster dose on administered on 09-Apr-2022; Nausea; No taste; Serious problem eating/No apatite; This spontaneous case was reported by a patient and describes the occurrence of AGEUSIA (No taste), DECREASED APPETITE (Serious problem eating/No apatite), WEIGHT DECREASED (Lost 20 Lbs), NAUSEA (Nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Booster dose on administered on 09-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (controlled with Medication) since 1985 and HIV disease (for 20 years taking medications.). Concomitant products included PROPRANOLOL HYDROCHLORIDE (INDERAL) for Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced AGEUSIA (No taste), DECREASED APPETITE (Serious problem eating/No apatite) and NAUSEA (Nausea). In 2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Booster dose on administered on 09-Apr-2022). On an unknown date, the patient experienced WEIGHT DECREASED (Lost 20 Lbs). The patient was treated with METOCLOPRAMIDE for Nausea, at a dose of 10 milligram as required; BIOTIN, CARBOHYDRATES NOS, FATS NOS, MINERALS NOS, POTASSIUM, PROTEINS NOS, SODIUM, VITAMINS NOS (BOOST) at an unspecified dose and frequency and NUTRIENTS NOS (ENSURE [NUTRIENTS NOS]) at an unspecified dose and frequency. At the time of the report, AGEUSIA (No taste), DECREASED APPETITE (Serious problem eating/No apatite), WEIGHT DECREASED (Lost 20 Lbs) and NAUSEA (Nausea) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Booster dose on administered on 09-Apr-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CD4 lymphocytes: normal before and after vaccination. On an unknown date, SARS-CoV-2 test: (Negative) Negative, done drive through about 2 months ago and (Negative) Negative. On an unknown date, Viral load: normal before and after vaccination.         The concomitant medications includes HIV medications.  On 26-Feb-2022, the patient received the second dose of Spikevax (batch number: unknown). On an unknown date, the patient received the first booster dose of Moderna COVID-19 vaccine. Patient visited the doctor again and after the fourth shot the problems continued.  Company Comment: This spontaneous case concerns a 68-year-old, male patient with current condition of human immunodeficiency virus infection receiving unspecified treatment who experienced the unexpected, non-serious adverse event of special interest of Ageusia which occurred in association with the second booster dose mRNA-1273. Inappropriate schedule of vaccine administered is noted in the case as the first and second booster doses were taken in less than 2 months after the second dose of mRNA-1273. There was no information regarding the administration date of the first booster dose. The patient developed Ageusia on the same year of vaccination with the first booster dose of mRNA-1273 along with other non-serious events of Decreased appetite, Weight decreased and Nausea. SARS-CoV-2 test showed negative result. CD4 cell count was normal before and after vaccination. The events became persistent and continued even after administration of the second booster dose. He consulted a physician, but diagnosis was not provided. He was started on oral nutrition therapy and prescribed with metoclopramide as needed for nausea. At the time of report, Ageusia has not recovered. The patient's advancing age and underlying HIV infection are considered confounders for the event Ageusia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-651068, MOD-2022-651069 (Patient Link).; Sender's Comments: This spontaneous case concerns a 68-year-old, male patient with current condition of human immunodeficiency virus infection receiving unspecified treatment who experienced the unexpected, non-serious adverse event of special interest of Ageusia which occurred in association with the second booster dose mRNA-1273. Inappropriate schedule of vaccine administered is noted in the case as the first and second booster doses were taken in less than 2 months after the second dose of mRNA-1273. There was no information regarding the administration date of the first booster dose. The patient developed Ageusia on the same year of vaccination with the first booster dose of mRNA-1273 along with other non-serious events of Decreased appetite, Weight decreased and Nausea. SARS-CoV-2 test showed negative result. CD4 cell count was normal before and after vaccination. The events became persistent and continued even after administration of the second booster dose. He consulted a physician, but diagnosis was not provided. He was started on oral nutrition therapy and prescribed with metoclopramide as needed for nausea. At the time of report, Ageusia has not recovered. The patient's advancing age and underlying HIV infection are considered confounders for the event Ageusia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.