Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: neck pain; Shoulder pain; Psoriasis flare-up/flare up in arms, knuckles and legs/had breakouts; Pericarditis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ARTHRALGIA (Shoulder pain), PSORIASIS (Psoriasis flare-up/flare up in arms, knuckles and legs/had breakouts) and PERICARDITIS (Pericarditis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis and METHOTREXATE for Rheumatoid arthritis.    The patient's past medical history included Psoriasis flare-up from 2009 to 2017. Previously administered products included for Gout: ALLOPURINOL since an unknown date. Past adverse reactions to the above products included No adverse event with ALLOPURINOL. Concurrent medical conditions included Smoker (smoker cigarette five stick in a day), Abstains from alcohol, Psoriatic arthritis (Moderate to severe chronic plaque psoriasis), Rheumatoid arthritis and High cholesterol. Concomitant products included BUMETANIDE (BUMEX) for Diuresis, SIMVASTATIN for High cholesterol, POTASSIUM and FOLIC ACID for an unknown indication.   In 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-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 METHOTREXATE (unknown route) at an unspecified dose. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Apr-2021, the patient experienced NECK PAIN (neck pain) (seriousness criterion hospitalization) and ARTHRALGIA (Shoulder pain) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up/flare up in arms, knuckles and legs/had breakouts) (seriousness criterion hospitalization). The patient was hospitalized from 12-Apr-2021 to 16-Apr-2021 due to PERICARDITIS and PSORIASIS. In June 2021, NECK PAIN (neck pain) and ARTHRALGIA (Shoulder pain) had resolved. At the time of the report, PSORIASIS (Psoriasis flare-up/flare up in arms, knuckles and legs/had breakouts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown and PERICARDITIS (Pericarditis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Ultrasound scan: pericarditis. On 09-Aug-2021, Ultrasound scan: no more fluid in the heart.         The concomitant medication Bumex was used as Diuretic It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Case level outcome was reported as recovering. She had chest tenderness and was so bad after three days while on the third week of Jul-2021  she felt much better. She could not breath and all the sudden her breathing got better. Physician advised that it could take three months for pericarditis to get better. On 12 Apr 2021 to 16 Apr 2021 the patient was hospitalized four days for reactions due to Covid vaccine. She had break out of psoriasis all over arms and legs due to Methotrexate.  The reporter's causality for the event(s) of covid-19 vaccine reaction, pericarditis, chest pain, neck pain, shoulder pain, cannot breath and chest tenderness with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of break out of psoriasis all over arms and legs with Humira(adalimumab)was a reasonable possibility.   The formulation for Humira was reported as Solution for injection in pre-filled pen  It was reported that patient experienced reaction to second covid injection. The treatment medication was not reported by reporter.  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.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 60-year-old female patient, with relevant medical condition of psoriatic arthritis and rheumatoid arthritis, who experienced the expected and serious (due to hospitalization and medically significant) AESI of Pericarditis, and the unexpected and serious (due to hospitalization) events of Psoriasis, Neck pain and Arthralgia (reported as Shoulder pain), which occurred after the second dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for psoriatic arthritis and plaque psoriasis. Patient started with chest tenderness 1 day after vaccination, and continued 3 days after with chest pain, neck pain, shoulder pain and dyspnoea. Ultrasound was performed, pericarditis was diagnosed, and patient was hospitalized for 5 days. New ultrasound performed approximately 4 months after vaccination showed no more fluid in the heart. Patient also experienced psoriasis flare up in arms, knuckles and legs in an unknown date, that was recovering at the time of the report. No information disclosed about treatments received. Underlying psoriatic arthritis and rheumatoid arthritis could be confounders for Pericarditis. Psoriasis  can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow-up document received and contains event pericarditis outcome and narrative updated. On 03-Dec-2021: Follow-up document received and contains suspect drug start date updated and new events added.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 60-year-old female patient, with relevant medical condition of psoriatic arthritis and rheumatoid arthritis, who experienced the expected and serious (due to hospitalization and medically significant) AESI of Pericarditis, and the unexpected and serious (due to hospitalization) events of Psoriasis, Neck pain and Arthralgia (reported as Shoulder pain), which occurred after the second dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Adalimumab for psoriatic arthritis and plaque psoriasis. Patient started with chest tenderness 1 day after vaccination, and continued 3 days after with chest pain, neck pain, shoulder pain and dyspnoea. Ultrasound was performed, pericarditis was diagnosed, and patient was hospitalized for 5 days. New ultrasound performed approximately 4 months after vaccination showed no more fluid in the heart. Patient also experienced psoriasis flare up in arms, knuckles and legs in an unknown date, that was recovering at the time of the report. No information disclosed about treatments received. Underlying psoriatic arthritis and rheumatoid arthritis could be confounders for Pericarditis. Psoriasis  can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.