Age: 22.0
Sex: M
Vaccine: FLUX, HPVX, MEN, MMR, TDAP
Symptoms: Laboratory test, Major depression, Muscle spasms, Mycobacterium tuberculosis complex test negative, Nausea
Clinical narrative: bipolar disorder; Major Depression; Syphilis; dryness in his face; Abdominal cramps; Diarrhea; Tachycardia; Anxiety; PTSD; Gynecomastia; skin break out; nausea; vomiting; feel palpitations; heart rate was climbing upwards of 120; night sweats; hot flashes; muscle spasm; Has been stressed; Missed 2 doses; out of medications; This serious case was reported by a physician via patient support programs and described the occurrence of bipolar disorder in a 24-year-old male patient who received cabotegravir, rilpivirine (Cabenuva) suspension for injection for hiv infection.   Co-suspect products included dolutegravir sodium, lamivudine (Dovato) film-coated tablet for hiv infection, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, HPV 16-18 (HPV vaccine) for prophylaxis, Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis, MMR (MMR vaccine) for prophylaxis, Influenza vaccine for prophylaxis and triamcinolone acetonide cream for rash.   Previously administered products included Biktarvy with an associated reaction of no adverse event. Concurrent medical conditions included smoker (Nicotine. Smoking 3-4 cig/day x age 17. Had not smoked for 1 and half years ago. Was vaping.), hiv infection, alcohol use (, Rarely, drinks 1-2x month and  drinks during those time mix drink), nicotine dependence and marijuana use. Additional patient notes included Other conditions were unknown. Family history included type ii diabetes mellitus (Paternal Grandfather, deceased, without complication, unspecified whether long term insulin use).   On an unknown date, the patient started Cabenuva (intramuscular) monthly. The dose was changed to every 2 months. On an unknown date, the patient started Dovato (oral) 1 dosage form(s) daily (1 dosage form(s) daily) and Tdap Vaccine. On 03-AUG-2022, the patient received HPV vaccine. On 24-MAR-2022, the patient received Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On an unknown date, the patient received MMR vaccine. On 20-NOV-2023, the patient received Influenza vaccine. On an unknown date, the patient started triamcinolone acetonide (topical) 0.1 %. On an unknown date, an unknown time after starting Cabenuva and Dovato and an unknown time after receiving Tdap Vaccine, HPV vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and MMR vaccine, the patient experienced bipolar disorder (Verbatim: bipolar disorder) (serious criteria GSK medically significant), major depression (Verbatim: Major Depression) (serious criteria GSK medically significant), syphilis (Verbatim: Syphilis) (serious criteria GSK medically significant), dry skin face (Verbatim: dryness in his face), abdominal pain (Verbatim: Abdominal cramps), diarrhea (Verbatim: Diarrhea), tachycardia (Verbatim: Tachycardia), anxiety (Verbatim: Anxiety), post-traumatic stress disorder (Verbatim: PTSD), gynecomastia (Verbatim: Gynecomastia), skin breakout (Verbatim: skin break out), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting), palpitation (Verbatim: feel palpitations), heart rate increased (Verbatim: heart rate was climbing upwards of 120), night sweat (Verbatim: night sweats), hot flashes (Verbatim: hot flashes), muscle spasm (Verbatim: muscle spasm), stress (Verbatim: Has been stressed), missed dose (Verbatim: Missed 2 doses), patient ran out of medication (Verbatim: out of medications). The patient was treated with propranolol hydrochloride (Inderal La), clomipramine hydrochloride (Clomipramine Hcl) and viloxazine hydrochloride (Qelbree). Cabenuva was interrupted. Dovato was continued with no change. The action taken with triamcinolone acetonide was unknown. The outcome of the bipolar disorder, dry skin face, abdominal pain, diarrhea, tachycardia, missed dose and patient ran out of medication were unknown and the outcome of the major depression, syphilis, anxiety, post-traumatic stress disorder, gynecomastia, skin breakout, nausea, vomiting, palpitation, heart rate increased, night sweat, hot flashes, muscle spasm and stress were not reported.   It was unknown if the reporter considered the bipolar disorder, major depression, syphilis, dry skin face, abdominal pain, diarrhea, tachycardia, anxiety, post-traumatic stress disorder, gynecomastia, skin breakout, nausea, vomiting, palpitation, heart rate increased, night sweat, hot flashes, muscle spasm and stress to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Dovato, Tdap Vaccine, HPV vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and MMR vaccine.     It was unknown if the company considered the bipolar disorder, major depression, syphilis, dry skin face, abdominal pain, diarrhea, tachycardia, anxiety, post-traumatic stress disorder, gynecomastia, skin breakout, nausea, vomiting, palpitation, heart rate increased, night sweat, hot flashes, muscle spasm and stress to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Dovato, Tdap Vaccine, HPV vaccine, Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine and MMR 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: 20 Mar 2024 This case was received via PharmaCord ViiV Connect HUB. Patient family history: father and mother were alive, unsure, not much communication. Paternal grandmother: deceased, Cancer unknown. maternal grandfather: alive, maternal grandmother alive, mother deported when he was a teen. Patient wanted to try patches/gum, currently vaping. Drugs included MJ (marijuana) smoking 3-4x per week, counseled about MJ and gynecomastia. Sexual orientation was gay, gender of sexual partner male, sex practices included oral, anal insertive, anal receptive. Prior STDs (sexually transmitted disease) and treatment recently diagnosed with syphilis and treated. No known drug allergy. Patient had no surgical history. Co-suspect included preventive medicine PCV13 in 2022, PPSV23 on 29 Jul 2021 and CV19 series on an unknown date. Patient was doing well on Cabenuva. He gets dryness in his face, which started with the second shot. He tried non-scented moisturizers, which caused him to break out. Now, he was doing sugar scrub and that worked well. Patient was currently on Dovato. He had nausea and vomiting, abdominal cramp, and diarrhea. Patient has missed 2 dosages this week because he has been trying to stretch out his medications since he was out of medications. For Bipolar disorder, patient was now on Clomipramine 50 mg and felt it working well. He was also started on Qelbree 1 month ago. He had noticed daily night sweats, hot flashes during the day and muscle spasms. For nicotine, he tried the patches, but then he started smoking again. Patient discontinued the nicotine patches and resumed vaping. Patient had been stressed and that was why he went back to smoking. He was also planning on moving to a new apartment and stressed about the move. Tachycardia- ever since his breakup, he had been feeling more anxious, would start propranolol. He would feel palpitations and notice his heart rate was climbing upwards of 120. General examination was normal, no abnormality found. Patient would continue Dovato while they try to reassess Cabenuva. Shingrix would recommend age 50, Anal Pap Smear would recommend age 30 and colonoscopy would recommend age 45. Quantiferon Gold test was negative in Nov 2023, UA (urine analysis) was normal in Nov 2023. Tobacco use cessation counseling done; started on patch. It was unknown if the reporter considered the events to be related to triamcinolone acetonide, meningococcal vaccine, influenza vaccine, measles vaccine, mumps vaccine, rubella vaccine (Mmr). This case was linked with US2024036448 due to same reporter.; Sender's Comments:  US-GSK-US2024036448:Same reporter US-VIIV HEALTHCARE LIMITED-US2023171797:Same reporter