Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product use issue, Respiratory disorder, Vascular rupture, Vessel puncture site haemorrhage, Wound
Clinical narrative: Uncontrolled asthma; Blood vessel burst in leg; Stream of blood started shooting out of it, went to ER; Respiratory issues; Orthoscopic knee surgery; Developed pneumonia; Had a cut on leg; This case was reported by a physician via other manufacturer and described the occurrence of pneumonia in a 58-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included dupilumab for asthma.   The subject's past medical history included asthma (patient had uncontrolled asthma).   On an unknown date, the patient received the 1st dose of Hz/su + AS01B. On 7th November 2019, the patient started dupilumab 300 mg at an unknown frequency. On 28th July 2021, the dose was changed to 600 mg at an unknown frequency. On 2nd August 2021, the dose was changed to 300 mg at an unknown frequency. In November 2020, less than 6 months after receiving Hz/su + AS01B, the patient experienced pneumonia (serious criteria GSK medically significant) and cut wound. In February 2021, the patient experienced arthropathy. On an unknown date, the patient experienced asthma, vascular rupture, vessel puncture site hemorrhage and respiratory disorder. The subject was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)). Dupilumab was interrupted. On an unknown date, the outcome of the pneumonia and cut wound were recovered/resolved and the outcome of the asthma and respiratory disorder were not recovered/not resolved and the outcome of the arthropathy, vascular rupture and vessel puncture site hemorrhage were unknown.   It was unknown if the reporter considered the pneumonia, asthma, vascular rupture, vessel puncture site hemorrhage, cut wound, arthropathy and respiratory disorder to be related to Hz/su + AS01B.  Additional details provided were as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and for shingles. In April 2020 or May 2020, the patient experienced blood vessel burst in his leg where a stream of blood started shooting out of it (vessel puncture site hemorrhage). It was also reported that the patient went to the emergency room (ER) and was injected with medication to stop bleeding. On an unknown date, the patient experienced potential lack of efficacy as patient had uncontrolled asthma on multiple therapies while on Dupilumab therapy with no adverse event reported. On an unknown date, in April 2020, the patient took his injection a month apart.The patient was back on Dupilumab and got his sample dose on 8th July 2020. It was reported that 6 months ago, patient had a cut to their leg (wound) and developed pneumonia. The events was resolved in 2020 or 2021. Three months ago patient had orthoscopic knee surgery. The patient was off of dupilumab and then he was on it sporadically with sample doses and was now getting back through the patient assistance program, they were about to restart after about 6 weeks (unknown date in 2021). At the time of reporting dupilumab was discontinued. On 28-Jul-2021, the patient started taking dupilumab injection of 600 mg dose once subcutaneously via use of medical device dupilumab pre-filled syringe for moderate persistent asthma uncomplicated. On follow up it was reported that after patient's last 3 injections, he was not experiencing the same efficacy as he had been On 2nd August 2021(latency: 1 year 8 months 3 weeks 5 days), consumer called his doctor because he was having trouble with asthma (Asthma) and respiratory issues (Respiratory disorder). Dupilumab was not working (Drug ineffective), and previous injection of Dupilumab 300 mg, prefilled syringe was on 28-Jul-2021. Doctor advised the consumer to take additional injection of the dupilumab 300 mg prefilled syringe a week earlier on 02-Aug-2021 (Off label use) (latency: 1 year 8 months 3 weeks 5 days) which he did and felt better 3 to 4 days later. Patient stated that he doubled up on the maintenance dose injection because once he administered the 1st dose of maintenance after a few days he did not feel any relief (Product use issue). Therefore, he took his Dupixent not as prescribed. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR221495:Same reporter.