Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, Pericarditis, SARS-CoV-2 test
Clinical narrative: tachycardia; interchange of vaccine products; Revaccination with different COVID-19 vaccine; Then, in Jun 2022 -Jul 2022 she got COVID; The pericarditis was in Sep 2021, 5 months after moderna series; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (The pericarditis was in Sep 2021, 5 months after moderna series) in a 43-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.     Concurrent medical conditions included Drug allergy (Sudafed allergy). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERICARDITIS (The pericarditis was in Sep 2021, 5 months after moderna series) (seriousness criterion medically significant). In June 2022, the patient experienced COVID-19 (Then, in Jun 2022 -Jul 2022 she got COVID). On an unknown date, the patient experienced TACHYCARDIA (tachycardia), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). In July 2022, COVID-19 (Then, in Jun 2022 -Jul 2022 she got COVID) had resolved. At the time of the report, PERICARDITIS (The pericarditis was in Sep 2021, 5 months after moderna series), TACHYCARDIA (tachycardia), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received Booster Pfizer vaccine in 26-Dec-2021 batch number- FE3594 and expiration- Feb 2022 anatomical location was reported as left arm, patient did not had any issues after the vaccine. In Jun-2022 to Jul-2022 patient got COVID-19. Patient experienced tachycardia, underwent echocardiograms and the tachycardia was benign. The doctor said that could be seen in patient with COVID.Patient took treatment with Paxlovid and had rebound COVID from that.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company Comment: This is a spontaneous case, reported by a consumer, concerning a 43 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) expected, AESI of pericarditis and non serious unexpected event of COVID-19. The event pericarditis occurred approximately 5 months after the second dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 1 year 1 month after vaccination with the second dose of mRNA-1273 vaccine and 6 months after the booster dose with Tozinameran. The outcome of the event COVID-19 was reported as recovered and not reported for the event pericarditis. Additionally, Interchange of vaccine products and Revaccination with different COVID-19 vaccine (vaccination with a booster dose of COVID-19 vaccine Tozinameran after primary series with mRNA-1273 vaccine) was noted in the case. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Follow Up significant information received relevant history, product coding, AE added and narrative updated.; Sender's Comments: Company Comment: This is a spontaneous case, reported by a consumer, concerning a 43 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) expected, AESI of pericarditis and non serious unexpected event of COVID-19. The event pericarditis occurred approximately 5 months after the second dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 1 year 1 month after vaccination with the second dose of mRNA-1273 vaccine and 6 months after the booster dose with Tozinameran. The outcome of the event COVID-19 was reported as recovered and not reported for the event pericarditis. Additionally, Interchange of vaccine products and Revaccination with different COVID-19 vaccine (vaccination with a booster dose of COVID-19 vaccine Tozinameran after primary series with mRNA-1273 vaccine) was noted in the case. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.