Age: 60.0
Sex: F
Vaccine: FLUA4
Symptoms: Pulmonary embolism, Upper respiratory tract infection
Clinical narrative: Pulmonary embolism; This clinical trial case, initially received on 05-Aug-2024 with additional information received on 06-Aug-2024 (processed together), was reported by a health professional and concerns an Elderly female subject.  Weight: 118.5 kg; Height: 171 cm  The subject was enrolled in the study  Past medical history included Nicotine dependance, Tubal Ligation. At the time of the event the subject had Generalized body pain, Hypertension, Generalized Back pain (due to previous herniated disc), Muscle spasms (due to previous back surgery), Morbid obesity, Allergy to bandaids, Osetoarthritis in spine, Osetoarthritis bilateral hands, Right rotator cuff tear, Right Biceps tendonitis, Bipolar II, Gastroesophageal reflux disease, insulin resistance, Vitamin D deficiency, Simple partial seizures, Mild Depression, Insomnia, Anxiety, Knee pain bilateral (due to previous meniscus tear), Peripheral Neuropathy bilateral feet, Hypercalcemia, Irritable bowel syndrome, Hypothyroidism. Concomitant medication: Fish oil for knee pain bilateral (due to previous meniscus tear), carbamazepine XR for simple partial seizures, Norco (hydrocodone bitartrate, paracetamol) for generalized Back pain (due to previous herniated disc), Advil (ibuprofen), Tylenol extra strength (paracetamol), and magnesium all used for generalized body pain, Pristiq (desvenlafaxine succinate monohydrate) for mild depression, amlodipine, Olmesartan/hctz (hydrochlorothiazide, olmesartan medoxomil) for hypertension, Lyrica (pregabalin) for peripheral neuropathy bilateral feet, vitamin D3 for vitamin D deficiency, Seroquel (quetiapine fumarate) for insomnia, Green tea extract (Camellia sinensis) and multivitamin as dietary supplements, lutein and zeaxanthin, both used as eye health supplements, phentermine and topiramate for morbid obesity, Levothyroxine for Hypothyroidism, aspirin (acetylsalicylic acid) and Plavix (clopidogrel bisulfate) for transient Ischemic attack. The subject's historical vaccine included influenza vaccine (brand not specified) on 06-Sep-2022 for an unknown indication. Back surgery for muscle spasm, what was known information was reported, did not received any records.  Administration of company suspect drug: On 22-Nov-2023 at 15:30, the subject received aQIVc HD  vs QIVr vs aQIV for Prophylaxis of influenza, Dose regimen: .5 ml, Route of administration: Intramuscular., Anatomical location: Left deltoid. The study vaccine was administered as per the protocol.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 17-May-2024, five  months and 26 days after receiving blinded study vaccine aQIVc HD  vs QIVr vs aQIV the subject experienced Pulmonary embolism (Medically Significant, outcome: Recovered / Resolved, stop date: 18-May-2024). The subject was presented to the Emergency Room (ER), and was admitted for observation. The subject was diagnosed with pulmonary embolism. The subject's concomitant medication Plavix was changed to Eliquis (apixaban).  The subject was admitted for 23-hour observation.  On 18-May-2024, the subject recovered from the event of pulmonary embolism and was discharged from hospital in a stable condition.   aQIVc HD  vs QIVr vs aQIV action taken: Not Applicable Treatment Medication: Eliquis 5 mg bid  Reporter's assessment: The reporter considered the event of pulmonary embolism as severe and serious due to the seriousness criterion of medical significance. The event was assessed as not related to the study vaccine and the alternative cause for the event was reported as concomitant disease.  Follow-up (03-Sep-2024) received from the investigator: hospitalization details was updated in narrative.  Follow-up (10-Sep-2024) received from the investigator: Influenza vaccine, Methylprednisolone, Amoxicillin and clavulanate potassium, Albuterol sulfate added as concomitant medications, Indication added for concomitant drug Tylenol extra strength as Upper respiratory infection, indication updated for Eliquis and updated to treatment drug from concomitant drug, narrative updated. Follow-up (01-Oct-2024) received from investigator: Dose of concomitant medication (levothyroxine) updated from 0.88 micrograms to 88 micrograms.   Follow-up (26-OCT-2024) from investigator: Received query response as records did not received after 3 attempts.  Linked Case ID(s): US-BEH-2024172303 (same patient) 29-OCT-2024 (System Update): Linked Case ID(s):2024172303 (Patient Link); Reporter's Comments: On 17-May-2024, five months and 26 days after receiving blinded study vaccine aQIVc HD  vs QIVr vs aQIV the subject experienced pulmonary embolism. In line with Investigator's assessment, the Sponsor assessed the event as not related to the study vaccine due to chronological and biological implausibility. Furthermore, the underlying morbid obesity, elderly age and hypertension are considered as risk factors for the reported event. Listedness was assessed using IB version 4.