Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bedridden, Cough, Ear pain
Clinical narrative: Lost of smell and test; Nausea; threw up; Head hurt; High fever (102.6 for two days, then went down to 100.2 to 100.9 and later increased to 101.6) that at the time of the call had disappeared; Sore arm; Felt sick after eating; Ears hurt and felt warm; Body aches; Coffing; Lost of smell and taste; Arm could not be lifted for a few days; She could not move out of her bed for three days.; Ears hurt and felt warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt sick after eating), EAR PAIN (Ears hurt and felt warm), MYALGIA (Body aches), COUGH (Coffing) and ANOSMIA (Lost of smell and taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE, PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEX), ESTRADIOL, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION COMPLICATION (Felt sick after eating), EAR PAIN (Ears hurt and felt warm), MYALGIA (Body aches), COUGH (Coffing), ANOSMIA (Lost of smell and taste), MOBILITY DECREASED (Arm could not be lifted for a few days), BEDRIDDEN (She could not move out of her bed for three days.), FEELING HOT (Ears hurt and felt warm), NAUSEA (Nausea), VOMITING (threw up), HEADACHE (Head hurt), PYREXIA (High fever (102.6 for two days, then went down to 100.2 to 100.9 and later increased to 101.6) that at the time of the call had disappeared) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced AGEUSIA (Lost of smell and test). At the time of the report, VACCINATION COMPLICATION (Felt sick after eating), EAR PAIN (Ears hurt and felt warm), FEELING HOT (Ears hurt and felt warm), NAUSEA (Nausea), VOMITING (threw up), HEADACHE (Head hurt) and PYREXIA (High fever (102.6 for two days, then went down to 100.2 to 100.9 and later increased to 101.6) that at the time of the call had disappeared) had resolved and MYALGIA (Body aches), COUGH (Coffing), ANOSMIA (Lost of smell and taste), MOBILITY DECREASED (Arm could not be lifted for a few days), BEDRIDDEN (She could not move out of her bed for three days.), AGEUSIA (Lost of smell and test) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Pyrexia: 102.6 (High) high fever (102.6 for two days, then went down to 100.2 to 100.9 and later increased to 101.6). On 30-Oct-2021, Pyrexia: 102.6 (High) high fever (102.6 for two days then went down to 100.2 to 100.9 and later increased to 101.6).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment drug reported.  Patient reported- she experienced similar symptoms but of a lower intensity after the second vaccination.  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 approximately 1 day after the booster dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events were reported after the second dose as well 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-2021-374141 (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 approximately 1 day after the booster dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events were reported after the second dose as well but the outcome was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.