Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder, Visual impairment
Clinical narrative: loss smell & taste; loss smell & taste; aches & pains; aches woke her up in middle of night; freezing to death; eyes are giving her trouble lately; usually sees well, but not so much lately; fever of 100.9F; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss smell & taste), AGEUSIA (loss smell & taste), PAIN (aches & pains), SLEEP DISORDER (aches woke her up in middle of night) and FEELING COLD (freezing to death) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (loss smell & taste, had a fever, and aches & pains) in March 2020. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ANOSMIA (loss smell & taste), AGEUSIA (loss smell & taste), PAIN (aches & pains), SLEEP DISORDER (aches woke her up in middle of night), FEELING COLD (freezing to death), OCULAR DISCOMFORT (eyes are giving her trouble lately), VISUAL IMPAIRMENT (usually sees well, but not so much lately) and PYREXIA (fever of 100.9F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. At the time of the report, ANOSMIA (loss smell & taste), AGEUSIA (loss smell & taste), PAIN (aches & pains), SLEEP DISORDER (aches woke her up in middle of night), FEELING COLD (freezing to death), OCULAR DISCOMFORT (eyes are giving her trouble lately) and VISUAL IMPAIRMENT (usually sees well, but not so much lately) outcome was unknown and PYREXIA (fever of 100.9F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 100.9 f (High) 100.9 F, 99 f (High) 99 F and 97 f (normal) 97 F.         No Concomitant medications were provided by the reporter. This case concerns an 87-year-old, female patient with a history of COVID-19 (in March 2021, with anosmia and ageusia) and recent vaccination with flu shot, who experienced the unexpected non-serious AESI events of anosmia and ageusia. The events occurred at an unknown day after the third dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the third dose and no additional dosing is expected. The medical history of COVID-19 (in March 2021, with anosmia and ageusia) and recent vaccination with flu shot remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-376660, MOD-2021-375073 (Patient Link).; Sender's Comments: This case concerns an 87-year-old, female patient with a history of COVID-19 (in March 2021, with anosmia and ageusia) and recent vaccination with flu shot, who experienced the unexpected non-serious events of anosmia and ageusia. The events occurred at an unknown day after the third dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since the events happened after the third dose and no additional dosing is expected. The medical history of COVID-19 (in March 2021, with anosmia and ageusia) and recent vaccination with flu shot remain as confounders. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.