Age: 82.0
Sex: M
Vaccine: COVID19, COVID19, FLUA3, FLUC3, FLUX, FLUX, PPV, SMALL, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, UNK, VARZOS, VARZOS
Symptoms: Macular degeneration, Metabolic encephalopathy, Oxygen saturation, Parkinson's disease, Pelvic pain
Clinical narrative: Basal cell carcinoma, face; pelvic pain; Actinic keratosis; parkinson's disease; Macular degeneration; GERD (Gastroesophageal reflux disease); Hypercholestermia; HCM-UTD with immunization; Eosinophilic esophagitis; Acute metabolic encephalopathy; Asthma with acute exacerbation; This serious case was reported by a physician via patient support programs and described the occurrence of parkinson's disease in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, abacavir sulfate, dolutegravir sodium, lamivudine (Triumeq) film-coated tablet for hiv infection, paracetamol (Acetaminophen) for drug use for unknown indication, salbutamol (Albuterol) for wheezing and shortness of breath, docusate sodium for constipation, hydrocortisone cream for rash aggravated, ipratropium bromide (Atrovent Hfa) for drug use for unknown indication, levothyroxine sodium (Synthroid) tablet for drug use for unknown indication, loratadine (Claritin) tablet for seasonal allergy, magnesium citrate for drug use for unknown indication, melatonin for drug use for unknown indication, ascorbic acid;betacarotene;cupric oxide;tocopheryl acetate;zinc oxide (Preservision Areds) capsule for drug use for unknown indication, omeprazole (Prilosec) capsule for drug use for unknown indication, oxycodone hydrochloride (Roxicodone) tablet for pain, pregabalin (Lyrica) capsule for drug use for unknown indication, quetiapine fumarate (Seroquel) tablet for drug use for unknown indication, rivastigmine (Exelon) capsule for drug use for unknown indication, senna spp. (Senna) tablet for drug use for unknown indication, tizanidine hydrochloride (Zanaflex) tablet for drug use for unknown indication, triamcinolone acetonide (Kenalog) cream for drug use for unknown indication, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for prophylaxis, TOZINAMERAN (COMIRNATY) for prophylaxis, INFLUENZA VACCINE (INFLUENZA TRIVALENT VACCINE) for prophylaxis, INFLUENZA VACCINE INACT SAG 3V (FLUAD) for prophylaxis, INFLUENZA VACCINE INACT SPLIT 4V (QUADRIVALENT INFLUENZA VACCINE) for prophylaxis, INFLUENZA VACCINE INACT SAG 3V (FLUCELVAX) for prophylaxis, Pneumococcal vaccine conj (Pneumococcal conjugate vaccine) for prophylaxis and SMALLPOX VACCINE for prophylaxis.   Previously administered products included Flublock (25-NOV-2023), Influenza trivalent vaccine, pneumococcal conjugate vaccine 13, Pneumococcal polysaccharides vaccine and TDAP. Concurrent medical conditions included hiv infection (sexually transmitted disease), dementia with lewy bodies, chronic kidney disease, esophageal stricture, cherry angiomas, heart murmur, nevus (multiple), eczema nummular, pneumonia, keratosis, tobacco abuse, verruca vulgaris, viral upper respiratory tract infection and drug allergy (Reactions were nausea and vomiting). Additional patient notes included no active allergies.   On 15-FEB-2023, the patient received the 2nd dose of Shingrix. On 08-DEC-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient started Triumeq (oral) 1 dosage form(s) daily (1 dosage form(s) daily) and Acetaminophen (oral) 1000 mg three times a day (3000 mg daily). The dose was changed to 500 mg twice a day (1000 mg daily). On an unknown date, the patient started Albuterol (inhaled) 2 puff(s) four times a day (8 puff(s) daily), docusate sodium (oral) 100 mg 1 dosage form(s) twice a day (2 dosage form(s) daily), hydrocortisone 2.5 % 20 g twice a day (40 g daily), Atrovent Hfa (inhaled) 2 puff(s) four times a day (8 puff(s) daily), Synthroid (oral) 175 mcg 1 dosage form(s) daily (1 dosage form(s) daily), Claritin (oral) 10 mg 1 dosage form(s) daily (1 dosage form(s) daily), magnesium citrate (oral) 100 mg daily (100 mg daily), melatonin (oral) 5 mg 1 dosage form(s) daily (1 dosage form(s) daily), Preservision Areds (oral) 2 dosage form(s) daily (2 dosage form(s) daily), Prilosec (oral) 20 mg daily (20 mg daily), Roxicodone (oral) 5 mg 1 dosage form(s) three times a day (3 dosage form(s) daily), Lyrica (oral) 25 mg 1 dosage form(s) twice a day (2 dosage form(s) daily), Seroquel (oral) 100 mg 1 dosage form(s) daily (1 dosage form(s) daily), Exelon (oral) 6 mg 1 dosage form(s) twice a day (2 dosage form(s) daily), Senna (oral) 8.6 mg 1 dosage form(s) twice a day (2 dosage form(s) daily), Zanaflex (oral) 2 mg 1 dosage form(s) three times a day (3 dosage form(s) daily) and Kenalog 0.1 %. On 21-SEP-2022, the patient received PFIZER BIONTECH COVID-19 VACCINE. On 30-APR-2022, the patient received COMIRNATY. On 20-OCT-2017, the patient received INFLUENZA TRIVALENT VACCINE. On 27-OCT-2022, the patient received FLUAD. On 09-OCT-2021, the patient received QUADRIVALENT INFLUENZA VACCINE. On 16-OCT-2019, the patient received FLUCELVAX. On 23-SEP-2022, the patient received Pneumococcal conjugate vaccine. On 24-AUG-2022, the patient received SMALLPOX VACCINE. On 20-JAN-2020, not applicable after receiving Shingrix and Shingrix and an unknown time after starting Triumeq, the patient experienced metabolic encephalopathy (Verbatim: Acute metabolic encephalopathy) (serious criteria GSK medically significant) and asthma aggravated (Verbatim: Asthma with acute exacerbation). On 14-FEB-2020, the patient experienced eosinophilic esophagitis (Verbatim: Eosinophilic esophagitis). On an unknown date, the patient experienced parkinson's disease (Verbatim: parkinson's disease) (serious criteria GSK medically significant), macular degeneration (Verbatim: Macular degeneration) (serious criteria GSK medically significant), basal cell carcinoma face (Verbatim: Basal cell carcinoma, face) (serious criteria GSK medically significant), pelvic pain (Verbatim: pelvic pain), actinic keratosis (Verbatim: Actinic keratosis), gastroesophageal reflux disease (Verbatim: GERD (Gastroesophageal reflux disease)), hypercholesterolemia (Verbatim: Hypercholestermia) and unevaluable event (Verbatim: HCM-UTD with immunization). Rechallenge with Shingrix was positive. Triumeq was continued with no change. Acetaminophen was continued with no change. Albuterol was continued with no change. Docusate sodium was continued with no change. Hydrocortisone was continued with no change. Atrovent Hfa was continued with no change. Synthroid was continued with no change. Claritin was continued with no change. Magnesium citrate was continued with no change. Melatonin was continued with no change. Preservision Areds was continued with no change. Prilosec was continued with no change. Roxicodone was continued with no change. Lyrica was continued with no change. Seroquel was continued with no change. Exelon was continued with no change. Senna was continued with no change. Zanaflex was continued with no change. Kenalog was continued with no change. The outcome of the parkinson's disease and pelvic pain were unknown and the outcome of the macular degeneration, metabolic encephalopathy, basal cell carcinoma face, actinic keratosis, asthma aggravated, eosinophilic esophagitis, gastroesophageal reflux disease, hypercholesterolemia and unevaluable event were not reported.   It was unknown if the reporter considered the parkinson's disease, macular degeneration, basal cell carcinoma face, pelvic pain, actinic keratosis, gastroesophageal reflux disease, hypercholesterolemia and unevaluable event to be related to Shingrix, Shingrix and Triumeq. It was unknown if the reporter considered the metabolic encephalopathy, asthma aggravated and eosinophilic esophagitis to be related to Triumeq.     It was unknown if the company considered the parkinson's disease, macular degeneration, basal cell carcinoma face, pelvic pain, actinic keratosis, gastroesophageal reflux disease, hypercholesterolemia and unevaluable event to be related to Shingrix, Shingrix and Triumeq. It was unknown if the company considered the metabolic encephalopathy, asthma aggravated and eosinophilic esophagitis to be related to Triumeq.   GSK receipt date: 20-MAR-2024 This case was received from physician. This report was submitted via the online direct entry reporting system. Patient was being companied by his partner. 83 year old male with history of HIV infection, lewy body dementia, chronic kidney disease, esophageal stricture. He was currently on Triumeq. Last Visit on Mar2023. He was enrolled a support program for caregivers of patients with dementia. Patient was currently on Triumeq (abacavir doiutegravir lamivudine) They indicated that they were less than 95 percentage compliant with the medications. Insurance or payment limitations on compliance had been none but needs financial assistance form signed annually. Personal barriers to compliance no. They were no side effects on to drugs. He was feeling well, no recent sexual transmitted disease.  New issue was Seeing an ortho surgeon on Feb2023 for left pelvic pain. No recent emergency room Visits. Review of system a comprehensive 12 point review of systems had been conducted, and was negative than otherwise outlined the interval history. Problem list was allergies and other relevant history reviewed and chart Was updated appropriately. Physical examination of patient was normal. Monkey pox vaccine reported as co suspect. It was unknown if the reporter considered all the events have been related to the suspects Acetaminophen, Albuterol. Docusate sodium, Hydrocortisone, Atrovent HFA, Synthroid, Claritine, Magnesium citrate, Melatonin, Presevison Areds, Roxicodine, Lyrica, Seroquel, Exelon, Senna, Zanaflex, Kenalog, Pfizer Biontech covid-19 vaccine, Comirnaty, Influenza Trivalent vaccine, Fluad, Influenza quadrivalent vaccine, Flucelvax, Pneumococcal conjugate vaccine, Small pox vaccine and monkey vaccine.