Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Myalgia, Nasopharyngeal swab, SARS-CoV-2 antibody test
Clinical narrative: Fatigue; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and MYALGIA (Muscle ache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033CZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included COVID-19 from August 2020 to 2020, Exhaustion from August 2020 to 2020 and Bunion operation (very extensive. big toe of right foot was repositioned and tendons were removed) on 07-May-2021. Concurrent medical conditions included Non-tobacco user, Alcohol use (ONE OR TWO DRINKS A WEEK), Drug allergy (SAVELLA ALLERGY MANIFESTED BY SEVERE TREMORS), Drug allergy (LYRICA ALLERGY MANIFESTED BY SEVERE TREMORS), Drug allergy (EMITREX ALLERGY MANIFESTED BY MIGRAINES), Alcohol allergy (BACARDI ALLERGY MANIFESTED BY MIGRAINES), Drug allergy (PROCARDIA ALLERGY MANIFESTED BY RASH AND HIVES), Drug allergy (WELLBUTRIN ALLERGY MANIFESTED BY MIGRAINES AND ANAPHYLAXIS), Rheumatoid arthritis (MODERATE TO SEVERE), Hypothyroidism, Acid reflux (esophageal), Anxiety, Depression, Fibrocystic disease of breast, Restless leg syndrome and Migraine. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), PIROXICAM (PAXIL [PIROXICAM]) for Anxiety and Depression, ARIPIPRAZOLE (ABILIFY) for Depression, IODINE for Fibrocystic disease of breast, LEVOTHYROXINE for Hypothyroidism, FREMANEZUMAB VFRM (AJOVY [FREMANEZUMAB VFRM]) for Migraine, MACROGOL 3350 (MIRALAX) for Restless leg syndrome, METHOTREXATE for Rheumatoid arthritis, CALCIUM and FOLIC ACID for Supplementation therapy, ASPIRIN [ACETYLSALICYLIC ACID] for Thrombosis prophylaxis.   In 2016, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK (Citrate Free). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK (Citrate Free). On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK (Citrate Free). In May 2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Muscle ache). The patient was treated with OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) at an unspecified dose and frequency. In May 2021, FATIGUE (Fatigue) and MYALGIA (Muscle ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Body temperature: More than 103 F fever. In August 2020, Nasopharyngeal swab: (Positive) Covid 19 positive. In 2021, Nasopharyngeal swab: (Negative) Negative for Covid 19 infection. In 2021, SARS-CoV-2 antibody test: (Positive) Positive for antibodies.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient allergic to parcardium.  The reporter's causality for the events fatigue and myalgia with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in   This case was linked to MOD-2021-628637 (Patient Link).