Age: 47.0
Sex: M
Vaccine: COVID19, COVID19, DTP, FLUX, FLUX, PPV, SMALL
Symptoms: Palpitations, Pulmonary mass, Respiratory tract infection, Sciatica, Spinal osteoarthritis
Clinical narrative: dyspnea; Palpitations/ heart murmur; chronic back pain; hearing loss; opioid dependence; Vitamin D deficiency; Esophagitis; Sebaceous cyst of skin; Lumbar spondylosis; Degeneration of lumbar or lumbosacral intervertebral disc; Sciatica of left side; anemia; pure hypercholesterolemia/hyperlipidemia; impaired fasting glycemia; GERD; Lung mass-Lung nodule; Acute bronchitis; COPD with acute lower respiratior infection; blood clot in leg; chronic obstructive lung disease; This serious case was reported by a nurse via patient support programs and described the occurrence of palpitation in a 62-year-old male patient who received dolutegravir sodium, lamivudine (Dovato) film-coated tablet for hiv infection.   Co-suspect products included salbutamol sulfate (Ventolin Hfa) inhaler for drug use for unknown indication, DTP (A or W not known) (DTP vaccine) for prophylaxis, azelastine hydrochloride (Azelastine) for drug use for unknown indication, buprenorphine;naloxone for drug use for unknown indication, vitamin d3 capsule for drug use for unknown indication, famotidine tablet for drug use for unknown indication, loratadine tablet for drug use for unknown indication, montelukast tablet for drug use for unknown indication, omeprazole modified-release tablet for drug use for unknown indication, sildenafil tablet for drug use for unknown indication, Elasomeran (COVID-19 vaccine Moderna) (batch number 05BE21A, expiry date 10-JAN-2022), (batch number 013L20A) and (batch number 011J20A) for prophylaxis, Tozinameran (Pfizer BioNTech COVID-19 vaccine) (batch number GJ3276, expiry date 17-NOV-2022) for prophylaxis, influenza vaccine (batch number 944496, expiry date 30-JUN-2024), (batch number 308519, expiry date 30-JUN-2022), (batch number T50707, expiry date 30-JUN-2015) and (batch number 1013273P, expiry date 31-MAR-2010) for prophylaxis, Influenza vaccine inact (Influenza vaccine inactivated) (batch number AS1595B, expiry date 30-JUN-2023) and (batch number UJ493AA, expiry date 30-JUN-2021) for prophylaxis, pneumococcal vaccine polysacch (Pneumococcal Polysaccharide Vaccine) for prophylaxis, smallpox vaccine live (Smallpox Vaccine) (batch number FDP00018, expiry date 31-OCT-2024) and (batch number FDP00002, expiry date 30-JUN-2023) for prophylaxis and fluticasone propionate nasal spray for drug use for unknown indication.   The patient's past medical history included marijuana use and caffeine consumption (Moderate). Concurrent medical conditions included smoker (Quit and started again in 2023. Cigarette smoker- 25 Apr 2023 Quit in Apr 2023. Started at age 19, smoked tobacco for 20 years. Less than 1/2 pack per day.) and hiv infection. Additional patient notes included Hypertension and diabetes run in family. Family history included diabetes mellitus (mother and brother), cancer (Bother with pancreatic cancer deceased) and hypertension (sister).   On an unknown date, the patient started Dovato and Ventolin Hfa (inhaled) 2 puff(s). On 20-NOV-2008, the patient received DTP vaccine. On an unknown date, the patient started Azelastine (inhaled) 2 puff(s) twice a day (4 puff(s) daily), buprenorphine;naloxone, vitamin d3, famotidine (oral) 40 mg 1 dosage form(s) daily (1 dosage form(s) daily), loratadine (oral) 10 mg 1 dosage form(s) daily (1 dosage form(s) daily), montelukast (oral) 10 mg 1 dosage form(s) daily (1 dosage form(s) daily), omeprazole 20 mg and sildenafil (oral) 100 mg 1 dosage form(s) daily (1 dosage form(s) daily). On 23-DEC-2020, the patient received COVID-19 vaccine Moderna. On 12-NOV-2022, the patient received Pfizer BioNTech COVID-19 vaccine. On 08-DEC-2009, the patient started influenza vaccine. On 06-NOV-2020, the patient received Influenza vaccine inactivated (intramuscular) .5 ml. On 11-NOV-2022, the dose was .5 ml. On 20-NOV-2008, the patient started Pneumococcal Polysaccharide Vaccine. On 16-SEP-2022, the patient started Smallpox Vaccine. On an unknown date, the patient started fluticasone propionate 50 mcg 4 puff(s) daily (4 puff(s) daily). In 2008, an unknown time after starting Dovato and Ventolin Hfa and an unknown time after receiving DTP vaccine, the patient experienced chronic obstructive pulmonary disease (Verbatim: chronic obstructive lung disease). In 2013, the patient experienced thrombosis leg (Verbatim: blood clot in leg) (serious criteria GSK medically significant). On 11-DEC-2018, the patient experienced palpitation (Verbatim: Palpitations/ heart murmur) (serious criteria hospitalization), acute bronchitis (Verbatim: Acute bronchitis) and respiratory infection (Verbatim: COPD with acute lower respiratior infection). On 05-FEB-2019, the patient experienced gastroesophageal reflux disease (Verbatim: GERD) and lung nodule (Verbatim: Lung mass-Lung nodule). On 11-APR-2019, the patient experienced fasting blood glucose abnormal (Verbatim: impaired fasting glycemia) and pure hypercholesterolemia (Verbatim: pure hypercholesterolemia/hyperlipidemia). On 15-MAY-2019, the patient experienced anemia (Verbatim: anemia). On 10-OCT-2019, the patient experienced sciatica (Verbatim: Sciatica of left side). On 22-OCT-2019, the patient experienced lumbar spondylosis (Verbatim: Lumbar spondylosis) and degeneration of lumbar or lumbosacral intervertebral disc (Verbatim: Degeneration of lumbar or lumbosacral intervertebral disc). On 21-MAR-2021, the patient experienced sebaceous cyst (Verbatim: Sebaceous cyst of skin). On 25-APR-2023, the patient experienced esophagitis (Verbatim: Esophagitis). On 15-FEB-2024, the patient experienced vitamin d deficiency (Verbatim: Vitamin D deficiency). On an unknown date, the patient experienced dyspnea (Verbatim: dyspnea) (serious criteria hospitalization), hearing loss (Verbatim: hearing loss) (serious criteria GSK medically significant), opioid type dependence (Verbatim: opioid dependence) (serious criteria GSK medically significant) and chronic back pain (Verbatim: chronic back pain). The patient was treated with warfarin sodium (Coumadin), ergocalciferol (Vitamin D2) and buprenorphine hydrochloride;naloxone hydrochloride (Suboxone). The action taken with Dovato was unknown. The action taken with Ventolin Hfa was unknown. The action taken with Azelastine was unknown. The action taken with buprenorphine;naloxone was unknown. The action taken with vitamin d3 was unknown. The action taken with famotidine was unknown. The action taken with loratadine was unknown. The action taken with montelukast was unknown. The action taken with omeprazole was unknown. The action taken with sildenafil was unknown. The action taken with Smallpox Vaccine was unknown. The action taken with fluticasone propionate was unknown. The outcome of the palpitation, hearing loss, thrombosis leg, opioid type dependence, anemia, chronic obstructive pulmonary disease, esophagitis, lumbar spondylosis, sciatica, lung nodule, fasting blood glucose abnormal, acute bronchitis, pure hypercholesterolemia, sebaceous cyst and respiratory infection were unknown and the outcome of the dyspnea and chronic back pain were not reported and the outcome of the gastroesophageal reflux disease, degeneration of lumbar or lumbosacral intervertebral disc and vitamin d deficiency were not resolved.   It was unknown if the reporter considered the dyspnea, hearing loss, opioid type dependence, anemia, esophagitis, lumbar spondylosis, degeneration of lumbar or lumbosacral intervertebral disc, sciatica, fasting blood glucose abnormal, pure hypercholesterolemia, vitamin d deficiency, sebaceous cyst and chronic back pain to be related to Dovato, Ventolin Hfa, Ventolin Hfa Metered Dose Inhaler Device and DTP vaccine. It was unknown if the reporter considered the palpitation, thrombosis leg, chronic obstructive pulmonary disease, gastroesophageal reflux disease, lung nodule, acute bronchitis and respiratory infection to be related to Ventolin Hfa, Ventolin Hfa Metered Dose Inhaler Device and DTP vaccine.     It was unknown if the company considered the dyspnea, hearing loss, opioid type dependence, anemia, esophagitis, lumbar spondylosis, degeneration of lumbar or lumbosacral intervertebral disc, sciatica, fasting blood glucose abnormal, pure hypercholesterolemia, vitamin d deficiency, sebaceous cyst and chronic back pain to be related to Dovato, Ventolin Hfa, Ventolin Hfa Metered Dose Inhaler Device and DTP vaccine. It was unknown if the company considered the palpitation, thrombosis leg, chronic obstructive pulmonary disease, gastroesophageal reflux disease, lung nodule, acute bronchitis and respiratory infection to be related to Ventolin Hfa, Ventolin Hfa Metered Dose Inhaler Device and DTP 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: 04-MAR-2024 This case was received via Health Authority. Appointment was on 14 Feb 2024. Co suspect included mpox vaccine, True Metrix Glucose Test Strip ones daily filled on 4 Feb 2023. Multivitamin tablet Take 1 tablet(s) every day by oral route, prescribed on 11 Jun 2023. On Dovato, he was undetectable with CD4 count of 443. Patient was for the routine follow up and voiced Interest In switch to Cabenuva injection to simplify his regimen. He denied any complaint currently. Patient said that he thought that he was missed diagnosed for asthma and no longer needeed the Montelukast. He believed that the GERD was related to taking his ART at night then going to bed. Said that he saw his dentist east week and the eye specialist three months ago. Last tabs were reviewed and was within normal limits with GFR (glomerular filtration rate) 87, creatinine 99. Patient had no known drug allergy. COVID-19 PCR test was negative on Dec 30. Patient had not traveled abroad recently. Had not been to an area known to be high risk for COVID-19. In the 14 days before symptom onset, had no close contact with a person who was under Investigation for COVID-19 while that person was ill or with a laboratory confirmed COVID-19 while that case was ill. Patient was current everyday smoker (quilt over year ago, started up again 2023 quit APR 2023). Not used any other form of tobacco. Never used electronic cigarettes, smokeless tobacco. The date of most recent tobacco screening response was 14 Feb 2024. Tobacco cassation counseling been provided on 09 Sep 2023. No alcohol consumption. Patient was able to care for themself. No difficulty seeing. No difficulty concentrating, remembering, or making decisions. No difficulty walking or climbing stairs. No difficulty dressing or bathing. No difficulty in doing errands alone. Was able to walk, without restrictions. No transportation difficulties. Patient did not feel isolated, had support system. Quit smoking in Aug 2018: Denied Smoking. It had been 3-6months since patient last smoked. Had hospital admission heart palpitations end dyspnea. Review of system: Patient reported no irritation, no sore throat, no chest pain, no cough and no shortness of breath. He reported no difficulty urinating, no muscle aches, no rashes. He reported no depression and no anxiety. He reported no fatigue, no swollen glands, no runny nose. Physical exam was normal. For vitamin D deficiency Vitamin D2 11250 mcg (50,000 unit) capsule-1 capsule every week by oral route for 30 days was prescribed. Will be switching to Cabenuva injection once approved. It was unknown if the reporter considered the events to be related Azelastine, Buprenorphine; Naloxone, Vitamin d3, Famotidine, Loratadine, Montelukast, Omeprazole, Sildenafil, fluticasone propionate nasal spray, COVID-19 vaccine moderna, Pfizer BioNTech COVID-19 vaccine, Influenza vaccine, Influenza vaccine inactivated Pneumococcal polysaccharide vaccine, Smallpox vaccine.; Sender's Comments:  US2024AMR001312:Same reporter