Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Fatigue, Illness, Mammoplasty, Myofascial pain syndrome
Clinical narrative: Pimples; Osteoarthritis; Myofascial pain syndrome; Cold symptoms; Psoriatic arthritis aggravated; Sickness; Generalized aching; Fatigue; Breast reduction; Surgical scar; This spontaneous case was reported by a consumer and describes the occurrence of PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated), ACNE (Pimples), MAMMOPLASTY (Breast reduction) and SCAR (Surgical scar) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    The patient's past medical history included Surgical scar and Breast reduction in October 2020. Concurrent medical conditions included Psoriatic arthritis.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In October 2020, the patient experienced MAMMOPLASTY (Breast reduction) (seriousness criterion medically significant) and SCAR (Surgical scar) (seriousness criterion medically significant). In August 2021, the patient experienced PAIN (Generalized aching) and FATIGUE (Fatigue). On 25-Aug-2021, the patient experienced ILLNESS (Sickness). In January 2022, the patient experienced PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated) (seriousness criterion medically significant) and NASOPHARYNGITIS (Cold symptoms). On an unknown date, the patient experienced ACNE (Pimples) (seriousness criterion medically significant), OSTEOARTHRITIS (Osteoarthritis) and MYOFASCIAL PAIN SYNDROME (Myofascial pain syndrome). In August 2021, ILLNESS (Sickness) had resolved. At the time of the report, PSORIATIC ARTHROPATHY (Psoriatic arthritis aggravated), ACNE (Pimples), OSTEOARTHRITIS (Osteoarthritis), MYOFASCIAL PAIN SYNDROME (Myofascial pain syndrome), NASOPHARYNGITIS (Cold symptoms), PAIN (Generalized aching) and FATIGUE (Fatigue) outcome was unknown and MAMMOPLASTY (Breast reduction) and SCAR (Surgical scar) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: High white blood cell count.    Company comment : This is a spontaneous case, reported by a consumer, concerning a 49-year-old female patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) events of Psoriatic arthropathy reported as psoriatic arthritis aggravated, and Acne reported as nipple pimples. Acne occurred on an unknown date, while the event Psoriatic arthropathy occurred approximately 10 months after receiving the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact event onset date was provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 4 months prior to third/booster mRNA-1273 vaccination. The patient also experienced sickness, osteoarthritis, myofascial pain syndrome, cold symptoms, and fatigue and body ache after booster dose of Moderna COVID-19 vaccine. Patient underwent white blood cell count with high result. No further details about the clinical course, other diagnostic procedures and treatments were provided. Outcome of the events Psoriatic arthropathy and Acne were unknown. The medical condition of Psoriatic arthritis remains as a confounder for the event Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.     No concomitant medicine were provided. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had breast reduction surgery in Oct 2020 due to that she had scar tissue in the left breast in Oct  2021 and did surgery to remove it. She also had high white blood cell count, osteoarthritis and myofascial pain disorder. She was sick for four days after receiving covid-19 vaccine on 25 Aug 2021 and had body aches and fatigue. From Sep 2021 to Jan 2022, she had psoriatic arthritis flare.  For HUMIRA, the reporter causality for the events of Breast reduction, Surgical scar, Pimples, Sickness, Osteoarthritis, Fatigue, White blood cell count high, Myofascial pain syndrome, Cold symptoms, Psoriatic arthritis and Generalized aching was not provided.  No treatment medicine were provided.   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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant Follow-up as events added.Inline correction done for downgrading the events Illness, Osteoarthritis, Myofascial pain syndrome, Fatigue, Nasopharyngitis, and Pain to Non-serious. Current Condition added, event deleted and Historical condition added.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 49-year-old female patient with relevant medical condition of Psoriatic arthritis, who experienced the unexpected serious (medically significant) events of Psoriatic arthropathy reported as psoriatic arthritis aggravated, and Acne reported as nipple pimples. Acne occurred on an unknown date, while the event Psoriatic arthropathy occurred approximately 10 months after receiving the first dose of mRNA-1273 vaccine. Latency cannot be properly assessed since the exact event onset date was provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 4 months prior to third/booster mRNA-1273 vaccination. The patient also experienced sickness, osteoarthritis, myofascial pain syndrome, cold symptoms, and fatigue and body ache after booster dose of Moderna COVID-19 vaccine. Patient underwent white blood cell count with high result. No further details about the clinical course, other diagnostic procedures and treatments were provided. Outcome of the events Psoriatic arthropathy and Acne were unknown. The medical condition of Psoriatic arthritis remains as a confounder for the event Psoriatic arthropathy. The benefit-risk relationship of mRNA-1273 is not affected by this report.