Age: 56.0
Sex: M
Vaccine: COVID19, COVID19-2, FLUX, TDAP, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, VARZOS
Symptoms: Back pain, Constipation, Erectile dysfunction, Fatigue, Glucose-6-phosphate dehydrogenase deficiency
Clinical narrative: ED (erectile dysfunction); heptatitis A immune; Chronic fatigue; Snoring; Daytime sleepiness; Other constipation; Other insomnia; Chronic bilateral low back pain without sciatica; paresthesia of right leg; HSV infection; Chronic allergic rhinitis; G6PD deficiency; Microalbuminuria; Vitamin D deficiency; trigger finger; visually impaired:yes; hyperglycemia; This serious case was reported by a nurse via patient support programs and described the occurrence of erectile dysfunction in a 58-year-old male patient who received cabotegravir, rilpivirine (Cabenuva) suspension for injection for hiv infection.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis, Influenza vaccine for prophylaxis, SMALLPOX VACCINE LIVE (MVA-BN) (JYNNEOS) for prophylaxis, davesomeran, elasomeran (Moderna Covid-19 Vaccine, Bivalent (Original And Omicron Ba.4/Ba.5)) for prophylaxis, ELASOMERAN (MODERNA COVID-19 VACCINE) for prophylaxis, atorvastatin calcium (Lipitor) tablet for product used for unknown indication, cetirizine hydrochloride (Zyrtec) tablet for product used for unknown indication, diclofenac (Voltaren) gel for product used for unknown indication, docusate sodium (Colace) capsule for product used for unknown indication, doxylamine succinate (Unisom) tablet for product used for unknown indication, vitamin d2 capsule for product used for unknown indication, insulin glargine (Basaglar Kwikpen) pen for product used for unknown indication, insulin lispro (Humalog) for product used for unknown indication, hydrochlorothiazide, losartan potassium (Hyzaar) tablet for product used for unknown indication, sildenafil citrate (Viagra) tablet for product used for unknown indication, fluocinolone acetonide (Synalar) for product used for unknown indication, gabapentin (Neurontin) capsule for product used for unknown indication, nystatin, triamcinolone acetonide (Mycolog-Ii) ointment for product used for unknown indication, macrogol 3350 (Glycolax) for product used for unknown indication and latanoprost (Xalatan) for product used for unknown indication.   The patient's past medical history included tenolysis (Tenolysis extensor tendon hand/finger each item). Concurrent medical conditions included polyneuropathy, mixed hyperlipidemia, asymptomatic hiv infection (infection status (nadir unknown), chlamydial infection, depression, type ii diabetes mellitus, essential hypertension, gonorrhea, hay fever, blood pressure high, syphilis, alcohol use (not currently), nonsmoker (e-cigarette/vaping use: never), hepatitis b (extended vaccination on 02 Apr 2020), allergy (hay fever) and pollen allergy (itching). Concomitant products included influenza vaccine inact sag 3v (Flucelvax).   On an unknown date, the patient started Cabenuva. On 22-MAR-2022, the patient received Tdap Vaccine. On 24-AUG-2022, the patient received Shingrix. On 12-JAN-2022, the patient received Influenza vaccine. On 05-AUG-2022, the patient received JYNNEOS. On 05-DEC-2022, the patient started Moderna Covid-19 Vaccine, Bivalent (Original And Omicron Ba.4/Ba.5). On 30-MAR-2021, the patient received MODERNA COVID-19 VACCINE. On an unknown date, the patient started Lipitor 10 mg, Zyrtec 10 mg, Voltaren 1 %, Colace 100 mg, Unisom 25 mg, vitamin d2 1250 mcg, Basaglar Kwikpen, Humalog, Hyzaar, Viagra 100 mg, Synalar 0.01 %, Neurontin 300 mg, Mycolog-Ii, Glycolax and Xalatan 0.005 %. On an unknown date, an unknown time after starting Cabenuva and an unknown time after receiving Tdap Vaccine and Shingrix, the patient experienced erectile dysfunction (Verbatim: ED (erectile dysfunction)) (serious criteria GSK medically significant), hepatitis a (Verbatim: heptatitis A immune), chronic fatigue (Verbatim: Chronic fatigue), snoring (Verbatim: Snoring), daytime sleepiness (Verbatim: Daytime sleepiness), constipation (Verbatim: Other constipation), insomnia (Verbatim: Other insomnia), low back pain (Verbatim: Chronic bilateral low back pain without sciatica), paresthesia lower limb (Verbatim: paresthesia of right leg), herpes simplex (Verbatim: HSV infection), allergic rhinitis (Verbatim: Chronic allergic rhinitis), glucose-6-phosphate dehydrogenase deficiency (Verbatim: G6PD deficiency), microalbuminuria (Verbatim: Microalbuminuria), vitamin d deficiency (Verbatim: Vitamin D deficiency), trigger finger (Verbatim: trigger finger), visual impairment (Verbatim: visually impaired:yes) and hyperglycemia (Verbatim: hyperglycemia). The action taken with Cabenuva was unknown. The action taken with Lipitor was unknown. The action taken with Zyrtec was unknown. The action taken with Voltaren was unknown. The action taken with Colace was unknown. The action taken with Unisom was unknown. The action taken with vitamin d2 was unknown. The action taken with Basaglar Kwikpen was unknown. The action taken with Humalog was unknown. The action taken with Hyzaar was unknown. The action taken with Viagra was unknown. The action taken with Synalar was unknown. The action taken with Neurontin was unknown. The action taken with Mycolog-Ii was unknown. The action taken with Glycolax was unknown. The action taken with Xalatan was unknown. The outcome of the erectile dysfunction, hepatitis a, chronic fatigue, snoring, daytime sleepiness, constipation, insomnia, low back pain, paresthesia lower limb, herpes simplex, allergic rhinitis, glucose-6-phosphate dehydrogenase deficiency, microalbuminuria, vitamin d deficiency, trigger finger, visual impairment and hyperglycemia were not reported.   It was unknown if the reporter considered the erectile dysfunction, hepatitis a, chronic fatigue, snoring, daytime sleepiness, constipation, insomnia, low back pain, paresthesia lower limb, herpes simplex, allergic rhinitis, glucose-6-phosphate dehydrogenase deficiency, microalbuminuria, vitamin d deficiency, trigger finger, visual impairment and hyperglycemia to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Tdap Vaccine and Shingrix.     It was unknown if the company considered the erectile dysfunction, hepatitis a, chronic fatigue, snoring, daytime sleepiness, constipation, insomnia, low back pain, paresthesia lower limb, herpes simplex, allergic rhinitis, glucose-6-phosphate dehydrogenase deficiency, microalbuminuria, vitamin d deficiency, trigger finger, visual impairment and hyperglycemia to be related to Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Tdap Vaccine and Shingrix.   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: 07-MAR-2024 This case was received from Nurse. Co-suspect included was BD Ultra-Fine Mini Pen needles 31 gaugex3/16 inch needle. Medication included Lancets (Accu-Chek Soficlex Lancets), blood sugar diagnostic strips, blood-glucose meter monitoring kit. Patient's smoking status, smokeless tobacco status, vaping use and drug use was never used. E-cigarette/vaping user was never used. No passive exposure. Counselling was given. Patient was on antiviral therapy. No disability status, hearing impaired. No special needs. Health Maintenance Modifiers: Hepatitis B: Indicated. Healthful Diet and Physical Activity Adults with CVD (Cardiovascular disease) Risk: Indicated. Hepatitis B: Not indicated. Dental prophylaxis: Indicated. Health maintenance: diabetes foot exam, Imm (Immunization)- Meningococcal (1-risk 2-dose series), Immunization- Pneumococcal (1-PCV), Retinopathy screening, colorectal cancer screening were never done. On 01-NOV-2023 patient had dental prophylaxis. On 17-MAY-2024 patient would have dental examination. On 14-AUG-2024, patient would have Diabetes HbA1c. On 11-OCT-2024, patient would have syphilis screening. On 14-FEB-2025 ,patient would have Diabetes Microalbumin with creatinine, lipid, serum creatinine screening. On 01-MAR-2025 ,patient would have tobacco screening. On 22-MAR-2032 patient would have Imm- DTap (Diphtheria, Tetanus, and Pertussis)/Tdap/Td (2-Td or Tdap). It was unknown if reporter considered event to be related to suspect.