Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: Loss of smell; Ears hurt and felt warm; sore arm that could not be lifted for a few days; arm that could not be lifted for a few days; She could not move out of her bed; Felt sick; felt warm; Coughing; Loss of taste; Nausea; threw up; Head hurt; High fever; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell), EAR PAIN (Ears hurt and felt warm), PAIN IN EXTREMITY (sore arm that could not be lifted for a few days), MOBILITY DECREASED (arm that could not be lifted for a few days) and BEDRIDDEN (She could not move out of her bed) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROXYCHLOROQUINE, PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEX), ESTRADIOL, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of smell), EAR PAIN (Ears hurt and felt warm), PAIN IN EXTREMITY (sore arm that could not be lifted for a few days), MOBILITY DECREASED (arm that could not be lifted for a few days), BEDRIDDEN (She could not move out of her bed), VACCINATION COMPLICATION (Felt sick), FEELING HOT (felt warm), COUGH (Coughing), AGEUSIA (Loss of taste), NAUSEA (Nausea), VOMITING (threw up), HEADACHE (Head hurt), PYREXIA (High fever) and MYALGIA (Body aches). At the time of the report, ANOSMIA (Loss of smell), EAR PAIN (Ears hurt and felt warm), PAIN IN EXTREMITY (sore arm that could not be lifted for a few days), MOBILITY DECREASED (arm that could not be lifted for a few days), BEDRIDDEN (She could not move out of her bed), VACCINATION COMPLICATION (Felt sick), FEELING HOT (felt warm), COUGH (Coughing), AGEUSIA (Loss of taste), NAUSEA (Nausea), VOMITING (threw up), HEADACHE (Head hurt), PYREXIA (High fever) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported by reporter.  This case concerns a 61 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of anosmia and ageusia. The events occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events were reported after the second dose but the outcome was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-374083 (Patient Link).; Sender's Comments: This case concerns a 61 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of anosmia and ageusia. The events occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events were reported after the second dose but the outcome was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.