Age: 31.0
Sex: M
Vaccine: COVID19, FLUX, HPVX, PPV, TD
Symptoms: Attention deficit hyperactivity disorder, Blood pressure measurement, Body temperature, Heart rate, Hepatic steatosis
Clinical narrative: Major depressive disorder; ADHD; Fatty liver; Obesity; This serious case was reported by a physician via patient support programs and described the occurrence of major depressive disorder, recurrent episode in a 34-year-old male patient who received cabotegravir, rilpivirine (Cabenuva) suspension for injection for product used for unknown indication.   Co-suspect products included HPV 16-18 (HPV vaccine) for prophylaxis, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (Adderall) for product used for unknown indication, escitalopram oxalate (Lexapro) for product used for unknown indication, famotidine (Pepcid Ac) for product used for unknown indication, mefenamic acid (Advil) for product used for unknown indication, ibuprofen (Motrin) for product used for unknown indication, Influenza vaccine (Flu) for prophylaxis, Pneumococcal vaccine for prophylaxis, Diphtheria vaccine toxoid, Tetanus vaccine toxoid (Td vaccine) for prophylaxis and COVID-19 vaccine for prophylaxis.   Concurrent medical conditions included hiv infection and major depression. Additional patient notes included No known allergies.   On an unknown date, the patient started Cabenuva (intramuscular). On 03-JUN-2021, the patient received HPV vaccine. On an unknown date, the patient started Adderall (oral) 15 mg, Lexapro (oral) 10 mg, Pepcid Ac, Advil (oral) 800 mg and Motrin (oral) 800 mg. On 01-AUG-2023, the patient received Flu. On 28-JAN-2021, the patient received Pneumococcal vaccine. On 17-FEB-2024, the patient received Td vaccine. On 30-DEC-2021, the patient received COVID-19 vaccine. On an unknown date, an unknown time after starting Cabenuva and an unknown time after receiving HPV vaccine, the patient experienced major depressive disorder, recurrent episode (Verbatim: Major depressive disorder) (serious criteria GSK medically significant), attention deficit hyperactivity disorder (Verbatim: ADHD), fatty liver (Verbatim: Fatty liver) and obesity (Verbatim: Obesity). The action taken with Cabenuva was unknown. The action taken with Adderall was unknown. The action taken with Lexapro was unknown. The action taken with Pepcid Ac was unknown. The action taken with Advil was unknown. The action taken with Motrin was unknown. The outcome of the major depressive disorder, recurrent episode, attention deficit hyperactivity disorder, fatty liver and obesity were unknown.   It was unknown if the reporter considered the major depressive disorder, recurrent episode, attention deficit hyperactivity disorder, fatty liver and obesity to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device and HPV vaccine.     It was unknown if the company considered the major depressive disorder, recurrent episode, attention deficit hyperactivity disorder, fatty liver and obesity to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device and HPV vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   GSK receipt date : 22 Mar 2024 This report was submitted. Other products were unknown. No review history was available from 21 Sep 2023 to 19 Mar 2024. On 11 Dec 2024 diabetes screening. It was unknown if the company considered the major depressive disorder, recurrent episode, attention deficit hyperactivity disorder, fatty liver and obesity to be related to suspect. Problem list included Attention deficit hyperactivity disorder (ADHD), combined type, Recurrent major depressive disorder, Obesity due to excess calories without serious, comorbidity, Fatty liver, HIV (human immunodeficiency virus infection). It was unknown if the reporter considered the major depressive disorder, recurrent episode, attention deficit hyperactivity disorder, fatty liver and obesity to be related to Flu, Td vaccine and COVID-19 vaccine.