Age: 61.0
Sex: M
Vaccine: FLUX, HEPA, PNC, PPV, TTOX, VARZOS, VARZOS
Symptoms: Treponema test negative
Clinical narrative: appendectomy; tonsils and adenoids surgery; chronic hip pain/ joint pain; chronic sinusitis; anxiety disorder, generalized; cellulitis of leg; depression; sinusitis; cough; joint swelling; edema; pneumonia; hx of spinal fusion/ neck fusion; pancreatic insufficiency; left hip surgery; polyp removal; This serious case was reported by a physician via patient support programs and described the occurrence of pneumonia in a 61-year-old male patient who received abacavir sulfate, dolutegravir sodium, lamivudine (Triumeq) film-coated tablet for hiv infection.   Co-suspect products included lamivudine, zidovudine (Combivir) film-coated tablet for hiv infection, Herpes zoster (Shingrix) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis, Hepatitis A vaccine for prophylaxis, valaciclovir hydrochloride (Valtrex) film-coated tablet for product used for unknown indication, bupropion hydrochloride (Wellbutrin) film-coated tablet for product used for unknown indication, PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX) for prophylaxis, Tetanus vaccine toxoid (Tetanus vaccin) for prophylaxis, levocetirizine dihydrochloride (Allegra) for product used for unknown indication, zolpidem tartrate (Ambien Cr) for product used for unknown indication, amlodipine besilate (Amlodipine) for hypertension, acetylsalicylic acid (Aspirin) for product used for unknown indication, hydrochlorothiazide, olmesartan medoxomil (Benicar Hct) for product used for unknown indication, clonidine hydrochloride (Catapres) tablet for product used for unknown indication, Centrum for product used for unknown indication, clonidine hydrochloride (Clonidine) for hypertension, vaccinium macrocarpon (Cranberry) for product used for unknown indication, citric acid, potassium bicarbonate (Effer K) for product used for unknown indication, hydralazine hydrochloride (Hydralazine) tablet for hypertension, lisinopril for hypertension, losartan potassium (Losartan) for product used for unknown indication, metoprolol succinate for hypertension, Multi Enzyme for product used for unknown indication, triamcinolone acetonide (Nasacort) nasal spray for product used for unknown indication, potassium gluconate (Potassium) tablet for product used for unknown indication, prednisone acetate (Prednisone) tablet for product used for unknown indication, lansoprazole (Prevacid) capsule for product used for unknown indication, promethazine hydrochloride (Promethegan) for product used for unknown indication, tamsulosin hydrochloride (Tamsulosin) capsule for product used for unknown indication, tizanidine hydrochloride (Tizanidine) capsule for product used for unknown indication, nevirapine (Viramune) for hiv infection, tenofovir disoproxil fumarate (Viread) for hiv infection, alprazolam (Xanax) for product used for unknown indication, sertraline hydrochloride (Zoloft) for product used for unknown indication, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for prophylaxis and INFLUENZA VACCINE (INFLUENZA) for prophylaxis.   The patient's past medical history included hepatitis a. Previously administered products included Sustiva and VZV vaccination. Concurrent medical conditions included hypertension, alcohol use (monthly or less (0-2 per day)), ex-tobacco user (Counselling cessation (Cigars 20-30 years, 2 per week)), acquired immunodeficiency syndrome, allergy to antibiotic and drug allergy. Additional patient notes included Risk of complications or morbidity or mortality: moderate.. Family history included cancer (aunt/ sister), type ii diabetes mellitus (aunt/ father. No colon/stomach/prostate cancer) and osteoporosis (grandmother).   In JAN-2016, the patient started Triumeq (oral) 1 dosage form(s) daily (1 dosage form(s) daily). On an unknown date, the patient started Combivir (oral). In OCT-2019, the patient received Shingrix. On an unknown date, the patient received Shingles vaccine. On 08-FEB-2016, the patient received Hepatitis A vaccine. On 04-OCT-2017, the patient started Valtrex (oral) 500 mg 1 dosage form(s) twice a day (2 dosage form(s) daily). On an unknown date, the patient started Wellbutrin (oral). On 08-FEB-2016, the patient received PNEUMOVAX and Tetanus vaccin. On an unknown date, the patient started Allegra (oral), Ambien Cr (oral), Amlodipine (oral), Aspirin (oral), Benicar Hct (oral), Catapres (oral) 0.1 mg, Centrum (oral), Clonidine .3 mg, Cranberry (oral), Effer K (oral), Hydralazine (oral) 100 mg, lisinopril (oral), Losartan (oral), metoprolol succinate (oral), Multi Enzyme (oral), Nasacort 55 ug, Potassium (oral) 99 mg, Prednisone (oral) 10 mg, Prevacid 15 mg, Promethegan (rectal), Tamsulosin (oral) .4 mg daily (.4 mg daily), Tizanidine (oral) 4 mg, Viramune (oral), Viread (oral), Xanax (oral) and Zoloft (oral). On 11-MAR-2016, the patient received PREVNAR. On 27-NOV-2018, the patient received INFLUENZA. In 2019, an unknown time after starting Triumeq, Combivir, Valtrex and Wellbutrin and an unknown time after receiving Shingrix, Shingles vaccine and Hepatitis A vaccine, the patient experienced polyp removal (Verbatim: polyp removal) (serious criteria clinically significant/intervention required). In AUG-2021, the patient experienced hip surgery (Verbatim: left hip surgery) (serious criteria clinically significant/intervention required). On an unknown date, the patient experienced pneumonia (Verbatim: pneumonia) (serious criteria GSK medically significant), spinal fusion (Verbatim: hx of spinal fusion/ neck fusion) (serious criteria clinically significant/intervention required), pancreatic insufficiency (Verbatim: pancreatic insufficiency) (serious criteria GSK medically significant), appendectomy (Verbatim: appendectomy) (serious criteria clinically significant/intervention required), adenotonsillectomy (Verbatim: tonsils and adenoids surgery) (serious criteria clinically significant/intervention required), arthralgia (Verbatim: chronic hip pain/ joint pain), chronic sinusitis (Verbatim: chronic sinusitis), anxiety (Verbatim: anxiety disorder, generalized), cellulitis of leg (Verbatim: cellulitis of leg), depression (Verbatim: depression), sinusitis (Verbatim: sinusitis), cough (Verbatim: cough), swollen joints (Verbatim: joint swelling) and edema (Verbatim: edema). Triumeq was continued with no change. The action taken with Combivir was unknown. The action taken with Valtrex was unknown. The action taken with Wellbutrin was unknown. The action taken with Allegra was unknown. The action taken with Ambien Cr was unknown. Amlodipine was continued with no change. The action taken with Aspirin was unknown. The action taken with Benicar Hct was unknown. The action taken with Catapres was unknown. The action taken with Centrum was unknown. Clonidine was continued with no change. The action taken with Cranberry was unknown. The action taken with Effer K was unknown. Hydralazine was continued with no change. The action taken with lisinopril was unknown. The action taken with Losartan was unknown. Metoprolol succinate was continued with no change. The action taken with Multi Enzyme was unknown. The action taken with Nasacort was unknown. The action taken with Potassium was unknown. The action taken with Prednisone was unknown. The action taken with Prevacid was unknown. The action taken with Promethegan was unknown. The action taken with Tamsulosin was unknown. The action taken with Tizanidine was unknown. The action taken with Viramune was unknown. The action taken with Viread was unknown. The action taken with Xanax was unknown. The action taken with Zoloft was unknown. The outcome of the pneumonia, spinal fusion, hip surgery, pancreatic insufficiency, polyp removal, appendectomy, adenotonsillectomy, chronic sinusitis, anxiety, cellulitis of leg, depression, sinusitis, cough, swollen joints and edema were not reported and the outcome of the arthralgia was not resolved.   It was unknown if the reporter considered the pneumonia, spinal fusion, hip surgery, pancreatic insufficiency, polyp removal, appendectomy, adenotonsillectomy, arthralgia, chronic sinusitis, anxiety, cellulitis of leg, depression, sinusitis, cough, swollen joints and edema to be related to Triumeq, Combivir, Shingrix, Shingles vaccine, Hepatitis A vaccine, Valtrex and Wellbutrin.     It was unknown if the company considered the pneumonia, spinal fusion, hip surgery, pancreatic insufficiency, polyp removal, appendectomy, adenotonsillectomy, arthralgia, chronic sinusitis, anxiety, cellulitis of leg, depression, sinusitis, cough, swollen joints and edema to be related to Triumeq, Combivir, Shingrix, Shingles vaccine, Hepatitis A vaccine, Valtrex and Wellbutrin.   GSK receipt date: 19 Dec 2023 This case was received from agency. The patient was initially presented on transfer of care from Referral Self, for an infectious disease's evaluation of HIV/AIDS. He transferred care because his had an insurance plan change. He reported that He acquired HIV homosexual contact. He reported the exposure occurred in 1999. The patient reported he was not sure if he had ever had an AIDS-defining illness He reported that his CD4 nadir was 200 to 300. He reported that he was taking Viramune, Combivir, Viread for HIV disease. He admitted to no side effects from his HIV medications. He stated that he was 100% adherent with his HAART. He stated that his last CD4 count was 1020 and viral load was undetectable. He reported a history of the following medications stopped for the described reasons: only remembered Sustiva. The patient had additional active problems, including the following diagnoses: hypertension. He was currently taking amlodipine and chlorthalidone/lisinopril, metoprolol, clonidine, hydralazine for hypertension. He reported his blood pressure was stable and well-controlled. He was having no side effects. Patient reported that, he was taking Triumeq for HIV. He reports no side effects from his HIV medications. He states that he was 100% adherent with his HAART. His last CD4 count was 940 and last HIV viral load was undetectable. These labs were drawn in the last week. The patient did not have any additional active problems. He denied additional or new problems. Patient had changed medication once or twice (remembers Sustiva, nothing else) since 1999. Started Triumeq in Jan 2016. Patient had medical history of chronic sinusitis, was on bph (benign prostatic hyperplasia) medications. PSA (prostate-specific antigen) was 4.7 on monday. Underwent right arthroscopy (in Apr 2015 and Sep 2018). Currently had chronic hip pain, history of spinal fusion and underwent left hip surgery in Aug 2021. Also had pancreatic insufficiency. STD (sexually transmitted diseases) screening: Hepatitis A infection in the past, no STDs. HCV (Hepatitis C) negative on 12 Feb 2016. RPR (rapid plasma reagin) and chlamydia negative in Nov 2019. Reported no sexual activity. Tuberculosis screening: Tspot in May 2020. Patient received Shingles vaccine in 2017 and Pfizer X 2 and booster in Oct 2021. Second booster and bivalent flu shot, RSV vaccine was on the day of report. Had polyp removal in 2019 and 2021 with scope (sonenshine) in 2019 and 2021. Had MMR (Measles, Mumps, and Rubella) titers checked. Patient had not hospitalized or not had antibiotics since last visit. Had dry cough for unclear duration. Needed medical assistance with Triumeq. The patient had denied: fever, chills, loss of appetite, blurred vision, headaches, dental problems, chest pain, irregular heartbeats, lower extremity edema, shortness of breath, wheezing, hoarseness, abnormal sputum production, pain on inspiration, genitourinary, nausea, vomiting, diarrhea, constipation, abdominal pain, change in bowel habits, urgency, frequency, dysuria, difficulty voiding, decreased force of stream, rash, pruritus, pigmentation changes, new skin lesions, changes to existing skin lesions, muscle pain, limitation of motion, muscle cramps. Patient's physical examination were, appearance: well-nourished, well developed, alert, in no acute distress. Atraumatic, normocephalic. Palpation: no tenderness or masses present, conjunctiva: normal conjunctiva, sclerae: sclerae white bilaterally. Pupils equal and round bilaterally, no relative afferent pupillary defect. Eyelids/Ocular Adnexa: eyelid appearance normal, no exudates present, eye moisture level normal. Neck Oropharynx: no inflammation or lesions present. External Ears: appearance within normal limits, no lesions present. Otoscopic Examination: tympanic membrane appearance within normal limits bilaterally, no tympanic membrane perforations present, tympanic membrane mobility normal bilaterally. External Nose: appearance normal. Oral Mucosa: oral mucosa normal. Lips: lip appearance normal. Teeth normal dentition for age. Gums: gums pink, non-swollen, tender, no bleeding present. Tongue: tongue appearance normal. Throat inspection/palpation: normal appearance, no masses or tenderness, trachea midline. Heart: Regular rate and rhythm. No edema. Subcutaneous tissue: general inspection: no rashes or lesions present, no areas of discoloration. Face: no rashes present, no lesions present, no areas of discoloration. Digits and Nails: no clubbing, cyanosis, deformities or edema present, normal appearing nails. Grossly oriented to person, place and time. Speech/Language: communication ability within normal limits, voice quality normal, articulation of speech normal, no evidence of aphasia. Mood and Affect: mood normal, affect appropriate. Chlorthalidone/lisinopril was continued with no change. It was unknown if the reporter considered the events to be related to allegra, ambien cr, amlodipine, aspirin, benicar hct, catapres, centrum, clonidine, cranberry, effer k, hydralazine, lisinopril, losartan, metoprolol succinate, multi enzyme, nasacort, potassium, prednisone, prevacid, promethegan, tamsulosin, tizanidine, viramune, viread, xanax, zoloft, prevnar, influenza, pneumovax, tetanus vaccine and chlorthalidone/lisinopril.