Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: Stomach aches/Stomach pain/After she went home she had stomach cramps; that resolved not too long after the shot.She has had a history of swelling in her legs and ankles; Swelling in arms/legs; had 2-3 asthma attacks; Couldn't breath/Short of breath/Gasping for air/where her breathing shut down, she couldn't breath; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of stomach pain in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) solution for injection in pre-filled pen for asthma.   The patient's past medical history included swelling of legs and ankle swelling.   In NOV-2023, the patient received Flu vaccine (intramuscular, right deltoid) and Nucala (subcutaneous). On an unknown date, an unknown time after receiving Flu vaccine and an unknown time after starting Nucala, the patient experienced stomach pain (Verbatim: Stomach aches/Stomach pain/After she went home she had stomach cramps), ankle swelling (Verbatim: that resolved not too long after the shot.She has had a history of swelling in her legs and ankles), swelling of legs (Verbatim: Swelling in arms/legs), asthmatic attack (Verbatim: had 2-3 asthma attacks), difficulty breathing (Verbatim: Couldn't breath/Short of breath/Gasping for air/where her breathing shut down, she couldn't breath) and sickness (Verbatim: Sick). The action taken with Nucala was unknown. The outcome of the stomach pain, asthmatic attack and difficulty breathing were resolved and the outcome of the ankle swelling, swelling of legs and sickness were not resolved.   It was unknown if the reporter considered the stomach pain, ankle swelling, swelling of legs, asthmatic attack, difficulty breathing and sickness to be related to Flu vaccine, Nucala and Nucala Autoinjector Device.   It was unknown if the company considered the stomach pain, ankle swelling, swelling of legs, asthmatic attack, difficulty breathing and sickness to be related to Flu vaccine, 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: 04-JAN-2024 The reporter received her first dose of Nucala at her physician's office.  The site of injection was left side of belly button in abdomen. She also received a flu shot at the time, too. After she went home, she had stomach cramps that resolved not too long after the shot.  She had a history of swelling in her legs and ankles but noted that they started to swell soon after these shots. She self-administered her second dose of Nucala with the autoinjector on 19th December 2023. She developed stomach cramps, stomach aches and stomach pain that all lasted for a week. She reported that since starting Nucala, she had 2-3 asthma attacks where her breathing shut down, she could not breath and she was gasping for air.  She described being sick right now and short of breath.  Her legs and ankles were also still swollen.  She believed the Nucala was causing her side effects. The reporter consented to follow up.