Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Hypersensitivity, Rash, Swelling face
Clinical narrative: allergic reaction/Face swelling/bilateral facial swelling; allergic reaction/Rash on feet and ankle/rash on her elbows, ankles, and feet; Rash on feet and ankle/rash on her elbows, ankles, and feet; This case was reported by a other health professional via call center representative and described the occurrence of allergic rash in a 80-year-old female patient who received mepolizumab (Nucala) solution for injection (batch number 9A9D, expiry date April 2025) for product used for unknown indication.   Co-suspect products included mepolizumab (Nucala) solution for injection in pre-filled pen (batch number Y84U, expiry date May 2023) for product used for unknown indication, mepolizumab autoinjector device (Nucala Autoinjector Device) administration system (batch number Y84U, expiry date May 2023) for product used for unknown indication and Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient started Nucala at an unknown dose (see dose text). On 29th March 2022, the dose was changed to 100 mg/ml at an unknown frequency. On 28th February 2022, the patient started Nucala 100 mg/ml at an unknown frequency and Nucala Autoinjector Device. On an unknown date, the patient received Shingrix. In March 2022, an unknown time after receiving Nucala, Nucala, Nucala Autoinjector Device and Shingrix, the patient experienced allergic rash and rash. On 4th April 2022, the patient experienced facial swelling. Nucala was discontinued (Dechallenge was positive). Nucala was discontinued (Dechallenge was positive). On an unknown date, the outcome of the allergic rash was unknown and the outcome of the rash and facial swelling were recovered/resolved.   The reporter considered the allergic rash and facial swelling to be related to Nucala and Shingrix. The reporter considered the allergic rash and rash to be related to Nucala, Nucala Autoinjector Device and Shingrix. It was unknown if the reporter considered the facial swelling to be related to Nucala and Nucala Autoinjector Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07 April 2022 Reporter's Comments: The case received via GSK response center. Very limited information provided by the reporter. Reporter (field representative) called on behalf of a nurse who reported adverse event (AE) that a patient had. Per the reporter, the nurse shared that a patient experienced allergic reaction from first and second dose of Nucala. Both first and second dose were give a month apart. The caller did not know when the injection was given, how it was given, how supplied (vial, Auto injector, prefilled syringe), when the AE occurred, and lot/expiry date for both doses. However, the reporter mentioned that from the first dose, the patient experienced rashes on feet and ankle. From second dose, the patient experienced face swelling.  Per reporter, the patient discontinued taking Nucala. Reporter not had patient's initials, date of birth, and did not ask the nurse for consent to follow-up with the nurse (Health care provider). However, the reporter provided contact information to the nurse regardless. Reporter did not ask the nurse for the consent for safety to follow-up. However, the reporter provided contact information to the nurse regardless.  Follow-up information received on 8-Apr-2022. This follow-up was considered significant.  Reporter's Comments: Patient was receiving both doses of Nucala SC at the HCP office. She started Nucala in September 2021 and never had issues with Nucala injections. She got the Shingles vaccine, but not sure of the date. She got a Nucala dose on 28 Feb 2022. A few days later had a rash on her elbows, ankles, and feet. She did not recall when the reaction started but she believed it was on March 1st or 2nd of 2022. She had her next dose on  29 Mar, 2022. After her dose on  29 Mar 2022, she had bilateral facial swelling (AE) on 4 Apr 2022. Her last dose of Nucala was on 29 Mar 2022. She did not recall the date when she had the Shingrix vaccine. It was reported as close to the date of 28 Feb 2022 when she got the Nucala injection. So she thought it was due to the Shingrix vaccine. Reporter stated that symptoms resolved a few days ago and Nucala was discontinued. Summary of Changes: event outcome, date, suspect product, causality, suspect product dates, new event, suspect product batch number and formulation