Received Jun 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
I am very stiff; Bladder infection; 2 spot on lungs; Weight gain; walking differently; Shingles shot/Arm is swollen; Headaches; Neck hurts; Coughing; Urinates 5 times last night; Injection is really painful; low thyroid; severe fatigue/ excessively tired/extreme fatigue; recently been having back pains/constant backache/ lower back pain/it only lasted 1 day; This serious case was reported by a consumer and described the occurrence of thyroid function decreased in a female patient who received mepolizumab (Nucala) solution for injection in pre-filled pen (batch number 693S, expiry date 31-JUL-2027) for asthma. Co-suspect products included mepolizumab (Nucala) solution for injection in pre-filled pen (batch number Y34F, expiry date 31-MAY-2027) for asthma and Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included urinary incontinence, sulfonamide allergy, allergy to molds, drug allergy (ALLERGIC TO CODEINE, GLUCOSAMINE) and penicillin allergy. Concomitant products included salbutamol sulfate (Albuterol Sulfate Hfa), loratadine, meclozine hydrochloride (Meclizine Hcl) and levocetirizine dihydrochloride (Xyzal). On 18-JUN-2024, the patient started Nucala (subcutaneous use) 100 mg every 4 weeks. On an unknown date, the patient started Nucala (subcutaneous use) 100 mg every 4 weeks and Shingles vaccine. In MAR-2025, an unknown time after starting Nucala and Nucala and an unknown time after receiving Shingles vaccine, the patient experienced fatigue (Verbatim: severe fatigue/ excessively tired/extreme fatigue). On an unknown date, the patient experienced thyroid function decreased (Verbatim: low thyroid) (serious criteria GSK medically significant), back pain (Verbatim: recently been having back pains/constant backache/ lower back pain/it only lasted 1 day), stiffness (Verbatim: I am very stiff), bladder infection (Verbatim: Bladder infection), lung disorder (Verbatim: 2 spot on lungs), weight gain (Verbatim: Weight gain), walking difficulty (Verbatim: walking differently), injection site swelling (Verbatim: Shingles shot/Arm is swollen), headache (Verbatim: Headaches), neck pain (Verbatim: Neck hurts), cough (Verbatim: Coughing), nocturia (Verbatim: Urinates 5 times last night) and injection site pain (Verbatim: Injection is really painful). The action taken with Nucala was unknown. Nucala was continued with no change. The outcome of the thyroid function decreased, fatigue, lung disorder, weight gain, injection site swelling, headache, neck pain, cough, nocturia and injection site pain were unknown and the outcome of the back pain was resolved (duration 1 day) and the outcome of the stiffness, bladder infection and walking difficulty were not resolved. It was unknown if the reporter considered the thyroid function decreased, back pain, fatigue, stiffness, bladder infection, lung disorder, weight gain, walking difficulty, injection site swelling, headache, neck pain, cough, nocturia and injection site pain to be related to Nucala, Nucala Autoinjector Device, Nucala, Nucala Autoinjector Device and Shingles vaccine. The company considered the thyroid function decreased to be unrelated to Nucala, Nucala Autoinjector Device, Nucala, Nucala Autoinjector Device and Shingles vaccine. It was unknown if the company considered the back pain, fatigue, stiffness, bladder infection, lung disorder, weight gain, walking difficulty, injection site swelling, headache, neck pain, cough, nocturia and injection site pain to be related to Nucala, Nucala Autoinjector Device, Nucala, Nucala Autoinjector Device and Shingles vaccine. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. GSK Receipt Date: 08-MAY-2025 and 13-MAY-2025. The patient reported that she had recently been experiencing back pains, walking differently, and feeling very tired/severe fatigue. She said, "I didn't want to do anything other than sleep. I had a constant backache that was on and off. When I got up to move, I was very stiff, and it took a moment for my body to start moving once I got up." She was unsure if this was due to age, a side effect of Nucala, or an issue with her thyroid. She stated that she had gained 60 pounds and also had a thyroid issue. She also reported feeling "excessively tired and experiencing lower back pain which began about a month ago." She mentioned a previous doctor visit where no issues were found, but a bladder infection was suggested. She denied any missed doses and was not scheduled to see the prescriber until June. She did not provide dates of onset and gave no other details. The prescriber was not aware of these events, and the patient stated she would notify them. The patient reported extreme fatigue starting in March 2025. She took Nucala for a cough. Due to teaching in a moldy classroom, she had recently retired. Her doctor had found 2 spots on her lungs. She had previously reported back pain, but it no longer hurt and had only lasted for 1 day. She reported having low thyroid function and severe stress in her life due to personal issues. She had gained weight due to fatigue. Follow up information received on 13-JUN-2025. Patient says she had the shingles shot, was coughing and says that her arm was swollen, headaches, acheing and neck hurts. She Was fine until she had the shot. Had to urinate 5 times last night. Patient says the injection really painful, when she gets the shot it hurts really bad. Summary of changes: Product tab, event tab and narrative updated.; Sender's Comments: Hypothyroidism is an unlisted event which is considered unrelated to GSK drugs Mepolizumab and Mepolizumab AUTOINJECTOR DEVICE.
Allergy to molds; Drug allergy (ALLERGIC TO CODEINE, GLUCOSAMINE); Penicillin allergy; Sulfonamide allergy; Urinary incontinence
ALBUTEROL SULFATE HFA; LORATADINE; MECLIZINE HCL; XYZAL; Nucala
Test Name: Weight; Result Unstructured Data: (Test Result:Incraesed,Unit:unknown,Normal Low:,Normal High:)