Age: 51.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Migraine, Pain assessment, Palpitations, Pulmonary embolism, Pyrexia
Clinical narrative: right lung pulmonary embolism; heart palpitations; fatigue worst; vomiting; low grade fever; low blood pressure; headache on and off; migraine; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Manufacturer (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-065358), license party for apixaban (ELIQUIS).  This case was received via Agency (Reference number: 20K-163-3399863-00) on 01-Jul-2021 and was forwarded to Manufacturer on 02-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (right lung pulmonary embolism) in 51-year-old female patient who received apixaban (ELIQUIS) for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included adalimumab (HUMIRA) solution for injection in pre-filled pen for Disease Crohns, methotrexate (OTREXUP) for an unknown indication and COVID-19 Vaccine for an unknown indication. The patient had Ileostomy bag for stool and she emptied her ileostomy bag about five times per day. Patient was not being able to do things friends can do. The patient's past medical history included Rectal bleeding (Patient had rectal bleeding with mucus. Patient had an unknown surgery on 31-Aug-2020 to remove the rectal area and other parts of the bowel because of heavy rectal bleeding. Patient almost always had stomach pain that moved to left side, blood and mucus from rectum) in 2020, Feeling unwell (Missing work because of not feeling well) in 2020, Disability, Appetite decreased NOS (not feeling hungry) in 2020, Weight loss (weight loss about seven pounds) in 2020, Nausea (On an unspecified date in May 2020, the patient experienced sore rectum area/both sides inside vagina/genital herpes outbreak. On 11-May-2020, the patient experienced chills/freezing, feeling drained/weak, bloated upper abdominal pain, nausea and bloated upper abdominal pain/stomach pain moving to left side. In 2020, stomach pain resolved) on 11-May-2020, Feeling sad, Stool bloody (liquid stool with blood), Smoker (everyday smoker), Abstains from alcohol, Back surgery, Fistula (fistula between vagina and rectum), Fatigue (Patient had fatigue which was present prior to HUMIRA had improved but still ongoing) in 2020, Anxiety in 2020, Depression, Kidney stones, Bleeding (The patient was hospitalized from 28-May-2020 to 06-Jun-2020 due to bleeding and pain. She was on disability and was not working. She had up to five liquid stools per day and after start of therapy symptoms worsened) in 2020, Arthralgia (especially in ankles) in 2020, Pain stomach in 2020, Difficulty sleeping, Chills (chills that felt like freezing) on 11-May-2020, Genital herpes in May 2020, Bloating on 11-May-2020, Rectal pain in May 2020, Injection site pain in 2020 and Stools watery in 2020. In December 2020, the patient started ELIQUIS (unknown route). On 17-Mar-2020, the patient started HUMIRA (Subcutaneous) 160 mg once, day 1. On 05-May-2020, the dose was changed to 80 mg once, day 15. In May 2020, the dose was changed to 40 milligram every week. In 2020, the dose was changed to 40 mg once in 14 days. On an unknown date, the patient started OTREXUP (unknown route). On 03-May-2021, the patient started COVID-19 Vaccine (unknown route). In 2020, the patient experienced MIGRAINE and HEADACHE (headache on and off). On 04-May-2021, the patient experienced VOMITING and PYREXIA (low grade fever). In May 2021, the patient experienced HYPOTENSION (low blood pressure). On 25-May-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 25-May-2021 to 27-May-2021 due to Pulmonary embolism. The patient was treated with paracetamol (TYLENOL) and alprazolam (XANAX). The action taken with ELIQUIS (Unknown) was unknown. In 2020, MIGRAINE resolved. In May 2021, VOMITING and PYREXIA resolved. At the time of the report, PULMONARY EMBOLISM, PALPITATIONS, HYPOTENSION and FATIGUE outcome was unknown and HEADACHE did not resolve. On 03-May-2021, the patient received COVID-19 vaccine and the next day patient had vomiting, low grade fever, headache which resolved in a week. On 21-May-2021, patient had pain in chest, trouble breathing was in emergency room on 24-May- 2021. She was admitted to hospital on 25-May-2021 and diagnosis of right lung pulmonary embolism done. Patient's blood pressure was low during hospitalization. Patient was discharged home on 27-May-2021. Patient's physician heard heart palpitations. Patient stated that chest was still sore, feels winded, but better than before. She reported fatigue worst, ongoing headaches, shortness of breath, feels cold and clammy since discharged unsure if these symptoms were from the lung embolism. The nurse saw the patient last time for consultation was 27-May-2020 and the last prescription refill was in Oct-2020. The patient was not advised to discontinued taking HUMIRA and from the most recent order of the doctor in 19-Jun-2020, the patient was due to continued taking HUMIRA. The strength of HUMIRA (adalimumab) was 40mg/0.4ml (40 mg, Solution for injection in pre-filled pen). The action taken with co-suspect drugs OTREXUP (methotrexate) and COVID-19 Vaccine were unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Pain assessment: 6 to 7 out of 10 and Weight: weight loss of three to four pounds. In May 2021, Blood pressure measurement: low. On 25-May-2021, Scan: right lung pulmonary embolism. For ELIQUIS (Unknown), the reporter did not provide any causality assessments.   Manufacturer Medical Evaluation Comment: This patient was hospitalised due to pulmonary embolism after receiving apixaban therapy along with adalimumab and methotrexate. This patient also get vaccinated for COVID-19. Underlying thromboembolic susceptibility as ascertained by the use of apixaban is likely the risk factor for the reported event and is considered as not related to the suspect.  Causality Assessments Drug: Eliquis Pulmonary embolism, Migraine, Palpitations, Intermittent headache, Fatigue aggravated, Vomiting, Low blood pressure and Low grade fever Per Reporter = No Information Per Company Manufacturer = Not Related; Sender's Comments: Manufacturer does not attribute the events to (ELIQUIS).