Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Condition aggravated, Dyspnoea, Inappropriate schedule of product administration, Injection site erythema
Clinical narrative: First dose of Shingrix on 9/11/2019 / Second dose of Shingrix not administered yet; Difficulty breathing; Asthma exacerbation; Redness on her left arm around injection site; Affected area was described as itchy; affected area was described was raised; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included seasonal allergy, asthma and rhinorrhoea (which typically occurs every fall). Concomitant products included antihistamine (Antihistamines).   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. On 12th September 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced difficulty breathing, asthma aggravated, injection site erythema, injection site itching and injection site swelling. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with prednisone. On 15th September 2019, the outcome of the difficulty breathing and asthma aggravated were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site itching, injection site swelling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the difficulty breathing, asthma aggravated, injection site erythema, injection site itching and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient said that the day before Shingrix vaccination had a runny nose which typically occurs every fall due to seasonal allergies from tree. At the time of vaccination the patient has being on anithistamines due to this. The patient reported medical history significant for acute asthma and bronchiole airways that overreacted. The patient received 1st dose of Shingrix and next day after vaccination, had difficulty breathing and an asthma exacerbation that lasted approximately 3 to 4 days. The patient went to an urgent care to undergo treatment and was prescribed Prednisone 60 milligram for 10 days. The reporter also reported redness on her left arm around the injection site that was approximately the size of a softball. The affected area was described as itchy and raise approximately 1/16th to 1/8th of an inch. The redness reportedly lasted over one week. The patient did not received 2nd dose of Shingrix till the time of report, which led to incomplete course of vaccination. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020209434:same reporter US-GLAXOSMITHKLINE-US2020209436:same reporter US-GLAXOSMITHKLINE-US2020209432:same reporter