Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Feeling abnormal, Interchange of vaccine products, Pain in extremity, Pericarditis
Clinical narrative: Arm hurt; Revaccination with different COVID-19 vaccine; INTERCHANGE OF VACCINE PRODUCTS; pericarditis; felt crappy; This spontaneous case was reported by a pharmacist and describes the occurrence of PERICARDITIS (pericarditis) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (primary vaccination series). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PERICARDITIS (pericarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), FEELING ABNORMAL (felt crappy), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS). The patient was treated with COLCHICINE for Pericarditis, at an unspecified dose and frequency. At the time of the report, PERICARDITIS (pericarditis) and PAIN IN EXTREMITY (Arm hurt) outcome was unknown and FEELING ABNORMAL (felt crappy), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (INTERCHANGE OF VACCINE PRODUCTS) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient received a Johnson and Johnson primary vaccination series followed by a booster dose of the Moderna COVID-19 vaccine.  It was reported that patient had every side effect possible with the first month of the Colchicine.  Company Comment :This is a spontaneous case, concerning a 72-year-old male patient, with no medical history reported, who experienced the serious expected AESI of Pericarditis, in an unknown date. The patient received primary vaccination series with JANSSEN COVID-19 VACCINE, followed by a booster dose of the mRNA-1273 vaccine. It is unclear the start date of the Pericarditis and if it will be after of before the administration of the booster dose of Moderna Vaccine.  After receiving the booster dose, patient experienced arm pain and he felt crappy for a day. In august he developed pericarditis and started Colchicine. He had every side effect possible with the first month of the Colchicine. JANSSEN COVID-19 VACCINE could be a confounder for the event. Latency cannot be assessed since onset date of the event was not disclosed clearly. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case, concerning a 72-year-old male patient, with no medical history reported, who experienced the serious expected AESI of Pericarditis, in an unknown date. The patient received primary vaccination series with JANSSEN COVID-19 VACCINE, followed by a booster dose of the mRNA-1273 vaccine. It is unclear the start date of the Pericarditis and if it will be after of before the administration of the booster dose of Moderna Vaccine.  After receiving the booster dose, patient experienced arm pain and he felt crappy for a day. In august he developed pericarditis and started Colchicine. He had every side effect possible with the first month of the Colchicine. JANSSEN COVID-19 VACCINE could be a confounder for the event. Latency cannot be assessed since onset date of the event was not disclosed clearly. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.