Sex: M
Vaccine: VARZOS
Symptoms: Dysuria, Influenza like illness, Micturition disorder, Muscle spasms, Therapy interrupted
Clinical narrative: Not being able to urinate; Feel like I had the flu; Leg Cramps at night; Urination dribble; Urination extremely painful; This case was reported by a consumer and described the occurrence of unable to urinate in a 56-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included TETANUS VACCINE TOXOID (TETANUS VACCINE) for prophylaxis, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for chronic obstructive pulmonary disease and fluticasone fur+umeclidinium+vilanterol ellipta dry powder inhaler device (Trelegy Ellipta Dry Powder Inhaler Device) inhaler (batch number unk, expiry date unknown) for chronic obstructive pulmonary disease.   Concurrent medical conditions included chronic obstructive pulmonary disease.   In February 2022, the patient received Shingles vaccine and TETANUS VACCINE. On an unknown date, the patient started Trelegy Ellipta at an unknown dose and frequency and Trelegy Ellipta Dry Powder Inhaler Device. On an unknown date, 3 days after receiving Shingles vaccine and less than 3 months after starting Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device, the patient experienced unable to urinate (serious criteria GSK medically significant), micturition disorder, painful urination, influenza like illness and leg cramps. Trelegy Ellipta was interrupted. On an unknown date, the outcome of the unable to urinate, micturition disorder and painful urination were recovered/resolved and the outcome of the influenza like illness and leg cramps were unknown.   It was unknown if the reporter considered the unable to urinate, micturition disorder, painful urination, influenza like illness and leg cramps to be related to Shingles vaccine. The reporter considered the unable to urinate, micturition disorder, painful urination, influenza like illness and leg cramps to be possibly related to Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he had been taking Trelegy for 3 months for chronic obstructive pulmonary disease (COPD). Last month from the reporting, the patient received a vaccine for shingles and tetanus at the same time during a visit with his primary care physician. The patient started to feel like he had the flu within 12 hours of the vaccine. On day 3 the patient had a sudden onset of not being able to urinate and when he did it was a dribble and extremely painful, it lasted for almost a week. The patient stopped Trelegy about 4 days into this as he saw that it might be a side effect. The patient enquired if it was related to Trelegy, the patient's primary physician did not know that it was a possible side effect and was not sure if he could start to use it again. The patient stated that Trelegy had done a great job with his COPD. The only other side effect the patient noticed was that he had more leg cramps at night when taking Trelegy. The wanted to know if GlaxoSmithKline had any guidance on this. The patient reiterated that again, it had been terrific treating his COPD.