Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac disorder, Herpes zoster, Pulmonary oedema
Clinical narrative: GOT SHINGLES THEN INFECTION WENT TO LEG, LUNGS AND HEART; FLUID ON LUNGS; OPEN HEART SURGERY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party.  A 78-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; apixaban (ELIQUIS), at 5 mg 2x/day, oral. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (hospitalization, medically significant), LOCALISED INFECTION (hospitalization, medically significant), VIRAL MYOCARDITIS (hospitalization, medically significant), LOWER RESPIRATORY TRACT INFECTION VIRAL (hospitalization, medically significant), outcome "unknown" and all described as "GOT SHINGLES THEN INFECTION WENT TO LEG, LUNGS AND HEART"; PULMONARY OEDEMA (hospitalization, medically significant), outcome "unknown", described as "FLUID ON LUNGS"; CARDIAC DISORDER (hospitalization, medically significant), outcome "unknown", described as "OPEN HEART SURGERY". The patient was hospitalized for herpes zoster, localised infection, viral myocarditis, lower respiratory tract infection viral, pulmonary oedema, cardiac disorder (start date: Aug2022). The action taken for apixaban was unknown. Therapeutic measures were taken as a result of pulmonary oedema, cardiac disorder.  Clinical course: On an unknown date, the patient experienced pulmonary oedema (fluid on lungs) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included had catheter to drain fluid from lungs. The outcome of the event is unknown. On an unknown date, the patient experienced herpes zoster (got shingles then infection went to leg, lungs and heart) which was considered serious due to hospitalization. The outcome of the event is unknown. On an unknown date, the patient experienced cardiac disorder (open heart surgery) which was considered serious due to the following criteria: hospitalization and medical significance. Treatment included Open heart surgery. The outcome of the event is unknown. The patient was on infusion. Patient had fluid on lungs. Patient had 2nd COVID shot and was in hospital, got shingles then infection went to leg, lungs and heart, had open heart surgery, had catheter to drain fluid from lungs. Patient had been in hospital last 2 1/2 weeks. No further information given. The status of apixaban medication is unknown. Medical history and concurrent conditions included Infusion, Catheter placement and Open heart surgery. Concomitant medications were not reported. The reporter did not provide a causal assessment for events pulmonary oedema, herpes zoster and cardiac disorder to product apixaban. The reporter did not provide a causal assessment for events pulmonary oedema, herpes zoster and cardiac disorder to product COVID-19 vaccine. Follow up has been performed.  Agency Comment: This patient had multiple events after receiving apixaban therapy.  Based on limited information regarding relevant medical history, concurrent medical conditions, it cannot be ascertained with reasonable possibility that the suspect drug contributed to the events pulmonary edema and cardiac disorder. Based on etiopathogenesis, shingles is considered not related to apixaban therapy.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Agency Comment: This patient had multiple events after receiving apixaban therapy.  Based on limited information regarding relevant medical history, concurrent medical conditions, it cannot be ascertained with reasonable possibility that the suspect drug contributed to the events pulmonary edema and cardiac disorder. Based on etiopathogenesis, shingles is considered not related to apixaban therapy.