Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Atrial fibrillation, COVID-19, Providencia infection
Clinical narrative: Providencia after 3rd ER- Atrial Defib noticed; Providencia after 3rd ER; Got diagnosed also with covid despite all the vaccinations; This spontaneous case was reported by a patient and describes the occurrence of ATRIAL FIBRILLATION (Providencia after 3rd ER- Atrial Defib noticed) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) for an unknown indication.    No Medical History information was reported.   On 24-Sep-2022, the patient received fifth dose of FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) (Intramuscular use) 1 dosage form. On an unknown date, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Providencia after 3rd ER- Atrial Defib noticed) (seriousness criterion medically significant), PROVIDENCIA INFECTION (Providencia after 3rd ER) and COVID-19 (Got diagnosed also with covid despite all the vaccinations). The patient was treated with RIVAROXABAN (XARELTO) at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Providencia after 3rd ER- Atrial Defib noticed), PROVIDENCIA INFECTION (Providencia after 3rd ER) and COVID-19 (Got diagnosed also with covid despite all the vaccinations) had resolved with sequelae.            No relevant concomitant medications were reported. The patient hasn't received any other vaccines on the same date as the Pfizer vaccine or within 4 weeks prior to first administration of the suspect vaccine. Patient had six COVID-19 vaccination shots intramuscularly only 5 was Pfizer (24 Sep 2022) all were Moderna. There were no predisposing factors. No antipyretic products were used around the date of vaccination. Patient had visited 3 times to ER, two to cardiologist and two to urgent care.  Company Comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the serious (due to medically significant) unexpected AESI of Atrial fibrillation, and the non-serious unexpected events of Providencia infection and COVID-19. The events Atrial fibrillation, and Providencia infection occurred on an unknown date, after a dose of SPIKEVAX COVID-19 VACCINE NOS, received as the third dose of COVID-19 vaccination schedule, and the event COVID-19 occurred on an unknown date after vaccination. The patient had received 6 doses in total: all were Moderna vaccines, except for dose 5 that was FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)). It was reported that the patient had visited 3 times to ER, two to cardiologist and two to urgent care; however, clinical course, supportive diagnostic procedures and treatment information, other than therapy with Xarelto, were not provided. The outcome of the events was reported as recovered with sequelae. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2024: Live follow-up received on 04-Jun-2024: updated reference and events added. On 04-Jun-2024: Live non-significant follow-up received on 04-Jun-2024: updated reference.