Age: 58.0
Sex: F
Vaccine: COVID19, FLUX, FLUX, HEP, MEN, PPV, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, VARZOS
Symptoms: Neuropathy peripheral, Osteonecrosis, Pigmentation disorder, Pneumonia
Clinical narrative: PNA (pneumonia); Avascular bone necrosis; neuropathy; Abdominal pain; Bronchitis; COVID-19; Depression; Dermatitis; Fall; Hypercalcemia; Hypertension; Intertrigo; Spinal stenosis of lumbar region; Hot flashes due to menopause; Adverse drug event; Sprain of right upper arm; Some hypo and hyper pigmented spots on her trunk and chest; family related stress; had 1 accident at work on the last episode; Diarrhea; This serious case was reported by a physician via patient support programs and described the occurrence of pneumonia in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, cabotegravir, rilpivirine (Cabenuva) suspension for injection for hiv infection, dolutegravir sodium (Tivicay) film-coated tablet for product used for unknown indication, salbutamol sulfate (Ventolin Hfa) inhaler for product used for unknown indication, Fluconazole (Flu) for prophylaxis, COVID-19 VACCINE for prophylaxis, amlodipine (Amlodipin) for product used for unknown indication, acetylsalicylic acid (Aspirin) for product used for unknown indication, bictegravir sodium;emtricitabine;tenofovir alafenamide fumarate (Biktarvy) tablet for product used for unknown indication, salbutamol sulfate (Albuterol Sulfate Hfa) inhalation powder for product used for unknown indication, loratadine (Claritin) tablet for product used for unknown indication, emtricitabine;tenofovir alafenamide fumarate (Descovy) tablet for product used for unknown indication, desloratadine tablet for product used for unknown indication, duloxetine hydrochloride (Duloxetine) prolonged-release capsule for product used for unknown indication, estradiol tablet for product used for unknown indication, gabapentin capsule for product used for unknown indication, efavirenz;emtricitabine;tenofovir disoproxil fumarate (Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate) for product used for unknown indication, hydrochlorothiazide capsule for product used for unknown indication, raltegravir (Isentress) for product used for unknown indication, mometasone furoate (Momentasone) nasal spray for product used for unknown indication, gabapentin (Neurontin) capsule for product used for unknown indication, Pneumococcal vaccine polyv (Pneumococcal vaccine polyvalent) for prophylaxis, Pneumococcal vaccine conj 13v (CRM197) (13 valent pneumococcal polysaccharide conjugate vaccine) for prophylaxis, MENINGOCOCCAL VACCINE CONJ (MENINGOCOCCAL CONJUGATE) for prophylaxis and Influenza vaccine (Influenza virus vaccine) for prophylaxis.   The patient's past medical history included ex-smoker (No household tobacco concerns) and hysterectomy. Concurrent medical conditions included hiv disease. Additional patient notes included No known allergies. Family history included diabetes mellitus (mother and father).   On an unknown date, the patient received Shingles vaccine. On 16-MAR-2017, the patient received Hepatitis B vaccine. On 14-NOV-2023, the patient started Cabenuva (intramuscular). On an unknown date, the patient started Tivicay, Ventolin Hfa (inhaled) 2 puff(s), Flu, COVID-19 VACCINE, Amlodipin (oral) 10 mg daily (10 mg daily), Aspirin (oral) 81 mg daily (81 mg daily), Biktarvy (oral) 1 dosage form(s) daily (1 dosage form(s) daily), Albuterol Sulfate Hfa (inhaled) 90 ug, Claritin (oral) 10 mg daily (10 mg daily), Descovy (oral), desloratadine (oral) 1 dosage form(s) daily (1 dosage form(s) daily), Duloxetine (oral) 30 mg twice a day (60 mg daily), estradiol (oral) 1 mg daily (1 mg daily), gabapentin (oral) 300 mg, Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (oral) 1 dosage form(s) daily (1 dosage form(s) daily), hydrochlorothiazide (oral) 12.5 mg, Isentress (oral) 400 mg twice a day (800 mg daily), Momentasone (inhaled) 50 ug daily (50 ug daily) and Neurontin (oral) 1 dosage form(s) three times a day (3 dosage form(s) daily). On 04-JUN-2019, the patient received Pneumococcal vaccine polyvalent. On 09-OCT-2018, the patient received 13 valent pneumococcal polysaccharide conjugate vaccine. On 16-MAR-2017, the patient received MENINGOCOCCAL CONJUGATE. On 09-OCT-2018, the patient received Influenza virus vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Hepatitis B vaccine and an unknown time after receiving Cabenuva, Tivicay, Ventolin Hfa, Flu and Amlodipin, the patient experienced pneumonia (Verbatim: PNA (pneumonia)) (serious criteria GSK medically significant), avascular necrosis of bone (Verbatim: Avascular bone necrosis) (serious criteria GSK medically significant), neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), abdominal pain (Verbatim: Abdominal pain), bronchitis (Verbatim: Bronchitis), covid-19 (Verbatim: COVID-19), depression (Verbatim: Depression), dermatitis (Verbatim: Dermatitis), diarrhea (Verbatim: Diarrhea), fall (Verbatim: Fall), hypercalcemia (Verbatim: Hypercalcemia), hypertension (Verbatim: Hypertension), intertrigo (Verbatim: Intertrigo), lumbar spinal stenosis (Verbatim: Spinal stenosis of lumbar region), menopausal hot flushes (Verbatim: Hot flashes due to menopause), adverse event (Verbatim: Adverse drug event), sprain (Verbatim: Sprain of right upper arm), spot pigmented (Verbatim: Some hypo and hyper pigmented spots on her trunk and chest), family stress (Verbatim: family related stress) and accident at work (Verbatim: had 1 accident at work on the last episode). The patient was treated with loperamide hydrochloride (Imodium). Cabenuva was continued with no change. The action taken with Tivicay was unknown. The action taken with Ventolin Hfa was unknown. The action taken with Amlodipin was unknown. The action taken with Aspirin was unknown. The action taken with Biktarvy was unknown. The action taken with Albuterol Sulfate Hfa was unknown. The action taken with Claritin was unknown. The action taken with Descovy was unknown. The action taken with desloratadine was unknown. The action taken with Duloxetine was unknown. The action taken with estradiol was unknown. The action taken with gabapentin was unknown. The action taken with Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate was unknown. The action taken with hydrochlorothiazide was unknown. The action taken with Isentress was unknown. The action taken with Momentasone was unknown. The action taken with Neurontin was unknown. The outcome of the pneumonia, avascular necrosis of bone, neuropathy, abdominal pain, bronchitis, covid-19, depression, dermatitis, fall, hypercalcemia, hypertension, intertrigo, lumbar spinal stenosis, menopausal hot flushes, adverse event, sprain and spot pigmented were unknown and the outcome of the diarrhea was unknown (duration 1 day) and the outcome of the family stress and accident at work were not reported.   It was unknown if the reporter considered the pneumonia, avascular necrosis of bone, neuropathy, abdominal pain, bronchitis, covid-19, depression, dermatitis, diarrhea, fall, hypercalcemia, hypertension, intertrigo, lumbar spinal stenosis, menopausal hot flushes, adverse event, sprain, spot pigmented, family stress and accident at work to be related to Shingles vaccine, Hepatitis B vaccine, Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Tivicay, Ventolin Hfa and Ventolin Hfa Metered Dose Inhaler Device.     It was unknown if the company considered the pneumonia, avascular necrosis of bone, neuropathy, abdominal pain, bronchitis, covid-19, depression, dermatitis, diarrhea, fall, hypercalcemia, hypertension, intertrigo, lumbar spinal stenosis, menopausal hot flushes, adverse event, sprain, spot pigmented, family stress and accident at work to be related to Shingles vaccine, Hepatitis B vaccine, Cabenuva, Cabenuva Needle Device, Cabenuva Syringe Device, Cabenuva Vial Adaptor Device, Tivicay, Ventolin Hfa and Ventolin Hfa Metered Dose Inhaler Device.   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: 19-Mar-2024 This case was received via RA. Patient had been generally well since last visit. She reported about day 7 following the Cabenuva she got diarrhea which last for 1 day. There were at least 5 episodes on that day, and she had 1 accident at work on the last episode. There was no nausea vomiting. She did take a heavy dairy diet on the last occurrence.  Her weight was stable. She was up to date on dentistry and ophthalmology. would reorder the Cologuard which she never got. She had the flu and COVID-vaccine. She declined RSV for now and might not completely qualify anyhow. She had shingles vaccine. She was in a monogamous heterosexual marriage.  She was continuing to work full-time. Patient health questionnaire: Feeling Down, Depressed, Hopeless: Not at all (14-Nov-2023), Initial depression screen score: 0 (14-Nov-2023), Little Interest: Pleasure in Activities: Not at all (14-Nov-2023). Review of systems: Family related stress. Physical examination: Skin: some hypo and hyper pigmented spots on her trunk and chest. Assessment plan: HIV disease, B20: Combined assessment: Patient's HIV status appeared stable.  She reported she had lab work over the last 2 weeks and would try to get those results. Cologuard ordered. She declined RSV (respiratory syncytial virus) vaccine at this time and might not be completely indicated at her age. She awaited dermatology evaluation soon. She had been on Cabenuva for 1 day which occurred about 1 week after Cabenuva dose. She was advised to try using lmodium perhaps to start on day 6 prophylactically. She would also have a mild diet avoiding dairy and fats around those days. She would call if there was a recurrent episode of diarrhea from the shot on the day of reporting. Would contact her after the labs were obtained. Continue Cabenuva (600/900 mg as directed). Injection was given during this visit. It was unknown if reporter considered pneumonia, avascular necrosis of bone, neuropathy, abdominal pain, bronchitis, covid-19, depression, dermatitis, diarrhea, fall, hypercalcemia, hypertension, intertrigo, lumbar spinal stenosis, menopausal hot flushes, hypercalcemia, adverse event, sprain, spot pigmented, family stress and accident to be related to Albuterol sulphate HFA, Amlodipine, Aspirin, Biktarvy, Claritin, Descovy, Desloratadine, Duloxetine, Efavirenz/emtriticabine /tenofovir disoproxil, Estradiol, Gabapentin, Hydrochlorothiazide, lsentress, Mometasone, Neurontin, Covid-19 vaccine, pneumococcal 23-polyvalent vaccine, pneumococcal 13-valent conjugate vaccine, meningococcal conjugate vaccine, influenza virus vaccine inactivated,  Flu. Reporter consented to contact.