Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Postural orthostatic tachycardia syndrome, Seizure, Spinal cord neoplasm
Clinical narrative: TUMORS ON SPINE; COLD; POTS DISEASE; SEIZURES; This is a spontaneous report received from a contactable reporter (consumer ) from License Party. Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-2022-106568 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 61 Year(s) old Female patient, who received Suspect product APIXABAN for Product used for unknown indication, Tablet, Oral (5 milligram(s) 2 every 1 Day), lot number:Unknown. On an unknown date, the patient experienced seizure(seizures) which was considered serious due to medical significance. Treatment included Surgery. The outcome of the event is unknown. On an unknown date, the patient experienced spinal cord neoplasm(tumors on spine) which was considered serious due to medical significance. The outcome of the event is unknown. On an unknown date, the patient experienced nasopharyngitis(cold) which was considered not serious. Treatment included Antibiotics. The outcome of the event is unknown. Patient stated she suffered from seizures and recently had surgery. Patient also had tumors on her spine and was currently suffering from a cold but was on antibiotics as treatment. No further information provided. The status of APIXABAN medication is unknown. Medical history and concurrent conditions included Surgery. Concomitant medications were not reported. The reporter did not provide a causal assessment for events seizure, spinal cord neoplasm and nasopharyngitis to product APIXABAN. Follow up has been performed. Tracking of Changes: 14-Sep-2022: Initial information was received.  Follow-up (07Mar2023): This is a spontaneous follow-up report received from a contactable reporter (consumer) from License Party. Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-2022-106568 (Bristol-Myers Squibb Company).   Information was received from a Consumer/other non health professional concerning a 61 Year(s) old Female patient, who received Suspect product APIXABAN (Tablet) via Oral (5 milligram(s) 2 every 1 Day) for Prophylaxis stroke, lot number: Unknown; Suspect product COVID-19 VACCINE for Product used for unknown indication, lot number:Unknown. In 2021, the patient had seizure (seizures), which met the following seriousness criteria: medical significance. Treatment included Surgery. The outcome of the seizure was unknown. On an unknown date, the patient had spinal cord neoplasm (tumors on spine), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the spinal cord neoplasm was unknown. On an unknown date, the patient had nasopharyngitis (cold), which was considered non-serious. Treatment included Antibiotics. The outcome of the nasopharyngitis was unknown. On an unknown date, the patient had postural orthostatic tachycardia syndrome (pots disease), which was considered non-serious. It is unknown if treatment was provided. The outcome of the postural orthostatic tachycardia syndrome was unknown. Patient stated she suffered from seizures and recently had surgery. Patient also had tumors on her spine and was currently suffering from a cold but was on antibiotics as treatment. No further information provided. Patient was started on Eliquis in 2018 and on it for 2.5 years before she started having seizures and its not related to Eliquis. Patient had 2 COVID vaccines then a booster then started having seizures 2021. Patient heart races when she was standing up. Patient feel herself its related to COVID vaccine. Patient seeing a cardiologist, she think its POTs disease. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included surgery. Concomitant medications were not reported. The reporter considered events seizure and postural orthostatic tachycardia syndrome not related to APIXABAN. The reporter did not provide a causality assessment for events spinal cord neoplasm and nasopharyngitis to APIXABAN. The reporter did not provide a causality assessment for events seizure, spinal cord neoplasm and nasopharyngitis to COVID-19 VACCINE. The reporter considered event postural orthostatic tachycardia syndrome related to COVID-19 VACCINE. Follow up has been performed. Tracking of Changes: 14-Sep-2022: Initial information was received. Follow-up received on 07-Mar-2023 provided no new information. Follow up received on 07-Mar-2023 from consumer with the following updates:  Product attributes updated for suspect product ELIQUIS. Suspect product COVID-19 VACCINE was added. New Event POTs (POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME) was added. Event attributes updated for the event SEIZURE and Narrative updated.  Eliquis is under agreement with BRISTOL-MYERS SQUIBB.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: This patient had seizures and spinal cord neoplasm after apixaban therapy. COVID-19 vaccine is a co-suspect.  Based on the malignant etiopathogenesis, spinal cord neoplasm is considered not related to the suspect therapy. Based on limited information regarding relevant medical history, seizure is considered not related to the suspect therapy.