Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pruritus
Clinical narrative: Localised itching; appetite absent; weakness; tiredness; nausea; muscle ache; joint pain; Headache; Straight hair curled; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (appetite absent), PRURITUS (Localised itching), HAIR TEXTURE ABNORMAL (Straight hair curled), ASTHENIA (weakness) and FATIGUE (tiredness) in a 52-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    There was no medical history reported by the reporter.  Concurrent medical conditions included Chronic fatigue, Raynaud's disease, Fibromyalgia and Endometriosis. Concomitant products included SULFASALAZINE and PREGABALIN (LYRICA) for an unknown indication.   In October 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 22-Dec-2020, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HAIR TEXTURE ABNORMAL (Straight hair curled). On 22-Apr-2021, the patient experienced DECREASED APPETITE (appetite absent), ASTHENIA (weakness), FATIGUE (tiredness), NAUSEA (nausea), MYALGIA (muscle ache), ARTHRALGIA (joint pain) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Localised itching). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form and DOXYCYCLINE ongoing since an unknown date at a dose of 1 dosage form. On 25-Apr-2021, DECREASED APPETITE (appetite absent), ASTHENIA (weakness), FATIGUE (tiredness), NAUSEA (nausea), MYALGIA (muscle ache) and ARTHRALGIA (joint pain) had resolved. At the time of the report, PRURITUS (Localised itching), HAIR TEXTURE ABNORMAL (Straight hair curled) and HEADACHE (Headache) had resolved. second dose      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The medical history was also reported as no tobacco use and abstain from alcohol.  The reporter's causality for the event(s) of HAIR TURNING CURLY FROM STRAIGHT and YEAST INFECTION/MILD ITCH onset in November 2020 with HUMIRA 40MG/0.4ML(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of NO APPETITE, VERY TIRED, WEAK, YEAST INFECTION/MILD ITCH unknown onset, NAUSEA, HEADACHE, MUSCLE ACHES and JOINT PAIN was not provided.  Relevant Laboratory & Other Diagnostic Tests:  November 2020 SPECULUM EXAM: Yeast infection  On 19 May 2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The events of "HAIR TURNING CURLY FROM STRAIGHT", "NO APPETITE", "VERY TIRED", "WEAK", "NAUSEA", "HEADACHE", "MUSCLE ACHES" and "JOINT PAIN" were added.   This case was linked to MOD-2021-179804 (Linked Report).; Sender's Comments:  MOD-2021-179804:Original Case : MOD-2021-179804(Dose 1)