Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: lack of taste; lack of smelling; arm sore; arm becoming a little red; not being to relax or sleep; feeling like he has the flu; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2022 and was forwarded to Moderna on 09-Feb-2022.    This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lack of taste), ANOSMIA (lack of smelling), PAIN IN EXTREMITY (arm sore), ERYTHEMA (arm becoming a little red) and INSOMNIA (not being to relax or sleep) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy and Bronchial asthma since 2014. Concomitant products included MEPOLIZUMAB (NUCALA) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Bronchial asthma.    On 07-Feb-2022 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, the patient experienced AGEUSIA (lack of taste), ANOSMIA (lack of smelling), PAIN IN EXTREMITY (arm sore), ERYTHEMA (arm becoming a little red), INSOMNIA (not being to relax or sleep) and INFLUENZA LIKE ILLNESS (feeling like he has the flu). At the time of the report, AGEUSIA (lack of taste), ANOSMIA (lack of smelling), PAIN IN EXTREMITY (arm sore), ERYTHEMA (arm becoming a little red), INSOMNIA (not being to relax or sleep) and INFLUENZA LIKE ILLNESS (feeling like he has the flu) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. Company comment This spontaneous case concerns a 75-year-old male patient, with medical history of COVID-19, who experienced the non-serious unexpected adverse events of special interest of Anosmia and Ageusia and other non-serious events. The events occurred in 1 day after receiving the first dose of mRNA-1273 Vaccine. As reported, the patient experienced arm sore, arm becoming a little red, feeling cold, shivering, dizzy, not being to relax or sleep, chills, very intense headaches, fatigue, discomfort, dragging, tiredness, lack of taste, smelling and appetite on the mid-afternoon of the same day of vaccination, no other clinical or treatment details were given. It was reported that the outcome of the events was resolving. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow up information received on 09/Feb/2022:  deleted the events with PTs: FEELING COLD, DISCOMFORT, DECREASED APPETITE, FEELING ABNORMAL, DIZZINESS, CHILLS, HEADACHE and FATIGUE as the event influenza like illness is already present.; Sender's Comments: This spontaneous case concerns a 75-year-old male patient, with medical history of COVID-19, who experienced the non-serious unexpected adverse events of special interest of Anosmia and Ageusia and other non-serious events. The events occurred in 1 day after receiving the first dose of mRNA-1273 Vaccine. As reported, the patient experienced arm sore, arm becoming a little red, feeling cold, shivering, dizzy, not being to relax or sleep, chills, very intense headaches, fatigue, discomfort, dragging, tiredness, lack of taste, smelling and appetite on the mid-afternoon of the same day of vaccination, no other clinical or treatment details were given. It was reported that the outcome of the events was resolving. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.