Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 antibody test positive
Clinical narrative: slow memory recall; Severe headache; Muscle aches; Fatigue; Nausea; Loss of taste; Loss of smell; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), MEMORY IMPAIRMENT (slow memory recall), HEADACHE (Severe headache) and MYALGIA (Muscle aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    Concurrent medical conditions included Hypothyroidism on 05-Jan-1999 and Postmenopause on 01-Apr-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 25-Nov-2020 to an unknown date and PROGESTERONE from 25-Nov-2020 to an unknown date for Menopause, LEVOTHYROXINE SODIUM (SYNTHROID) from 15-Jan-1999 to an unknown date for thyriod.   On 30-Dec-2020 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ACETYLSALICYLIC ACID (BABY ASPIRIN) (Oral) 81 milligram. On 02-Jan-2021, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), HEADACHE (Severe headache), MYALGIA (Muscle aches), FATIGUE (Fatigue) and NAUSEA (Nausea). On an unknown date, the patient experienced MEMORY IMPAIRMENT (slow memory recall). In January 2021, HEADACHE (Severe headache), MYALGIA (Muscle aches) and NAUSEA (Nausea) had resolved. At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), MEMORY IMPAIRMENT (slow memory recall) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 antibody test positive: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 26-Dec-2020, this patient was exposed to a family member who had fever and headache. One week later the family member was confirmed to be COVID positive. She was advised to go ahead with getting the vaccine. Treatment for the event included acetaminophen, vitamins C,E,D,Z, and melatonin.   This case was linked to MOD-2021-089996 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up information was received from the patient updating the reported events, event onset date, event outcomes and concomitant product used.; Sender's Comments: The event SARS-CoV-2 test positive is unlikely related to the mRNA-1273, since this vaccine does not contain a virus capable of causing infection. Although, for all other events reported (headache, myalgia, chills, pyrexia, fatigue, nausea, ageusia, anosmia, cough and nasal congestion) a causal relationship cannot be excluded, based on the current available information and temporal association between the use of the product and the start date of the events.