Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RSV | RSV (AREXVY) | GLAXOSMITHKLINE BIOLOGICALS | UNK | EA4RB | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 9Y92F | — |
Right knee surgery; Orthopedic Surgery; Nasal discharge; insomnia; nausea; sinus infection; bilateral pneumonia; This serious case was reported by a consumer and described the occurrence of bilateral pneumonia in a 72-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EA4RB) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) (batch number 9Y92F) for prophylaxis, mepolizumab (Nucala) solution for injection in pre-filled syringe (batch number UX7C, expiry date 31-JAN-2027) for asthma and budesonide for product used for unknown indication. The patient's past medical history included cataract operation, cataract operation, appendectomy and knee injury (orthopedic surgery on 23-JUN-2023). Previously administered products included Pregabalin with an associated reaction of no adverse event, Pregabalin with an associated reaction of no adverse event (BID), ProAir with an associated reaction of no adverse event and Singulair with an associated reaction of no adverse event. Concurrent medical conditions included chronic cough (for several years.), alcohol use (occasional), asthma (ER visit for asthma), bronchitis, sinusitis, seasonal allergic rhinitis, drug allergy (Budosenide), grass allergy, pollen allergy, food allergy, multiple allergies and hay fever. Additional patient notes included Patient had animal exposure, patient was a nonsmoker and patient never used electronic cigarettes.. Concomitant products included fluticasone furoate;umeclidinium bromide;vilanterol trifenatate (Trelegy Ellipta), fexofenadine hydrochloride (Allegra Allergy), calcium, magnesium, colecalciferol (Vitamin D3), menaquinone (Vitamin K2), levocetirizine dihydrochloride (Xyzal), azithromycin, salbutamol sulfate (Albuterol Sulfate Hfa), amoxicillin, clavulanate potassium (Potassium Clavulanate), benzonatate, doxycycline hyclate, erythromycin, prednisone, COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), INFLUENZA VACCINE, INFLUENZA VACCINE and tiotropium bromide (Spiriva). On 14-OCT-2023, the patient received Arexvy. On 18-APR-2024, the patient received Shingrix. On 05-MAY-2021, the patient started Nucala (subcutaneous) 100 mg every 4 weeks. On an unknown date, the patient started budesonide twice a day. On 16-JAN-2025, 460 days after receiving Arexvy, 273 days after receiving Shingrix, 1352 days after starting Nucala and an unknown time after starting budesonide, the patient experienced bilateral pneumonia (Verbatim: bilateral pneumonia) (serious criteria GSK medically significant). On 12-JUN-2025, the patient experienced sinus infection (Verbatim: sinus infection). On an unknown date, the patient experienced knee operation (Verbatim: Right knee surgery) (serious criteria clinically significant/intervention required), orthopedic procedure (Verbatim: Orthopedic Surgery) (serious criteria clinically significant/intervention required), nasal discharge (Verbatim: Nasal discharge), insomnia (Verbatim: insomnia) and nausea (Verbatim: nausea). The patient was treated with levofloxacin (Levaquin) and methylprednisolone (Medrol). Nucala was continued with no change. Budesonide was discontinued. The outcome of the bilateral pneumonia was resolving and the outcome of the knee operation, orthopedic procedure, nasal discharge, sinus infection, insomnia and nausea were not reported. It was unknown if the reporter considered the bilateral pneumonia, knee operation, orthopedic procedure, nasal discharge, sinus infection, insomnia and nausea to be related to Arexvy, Shingrix, Nucala and Nucala Pre-Filled Syringe Device. It was unknown if the reporter considered the bilateral pneumonia, knee operation, orthopedic procedure, nasal discharge, sinus infection and insomnia to be related to budesonide. The reporter considered the nausea to be related to budesonide. The company considered the bilateral pneumonia, knee operation and orthopedic procedure to be unrelated to Arexvy, Shingrix, Nucala and Nucala Pre-Filled Syringe Device. The company considered the nausea to be related to budesonide. 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: 19-MAY-2025 This information was received from consumer.. Patient had pneumonia but feeling much better. Follow up received on 09-JUL-2025 The patient had cough. Severity was she was able to sleep during episode Onset/Timing was greater than equal to 2 days per week, Status was improving. She had a history of ER visit for asthma. On 16 Jan 2025, she was here after recent visit to ER on 08 Jan 2025. She had hx of fevers, chills, headache, body aches, productive cough, chest pain while coughing, decreased appetite, and generalized fatigue x 6 day. She was diagnosed with bilateral pneumonia in the ER and prescribed Levaquin. She was doing better. On 27 Jan 2025, she presented with night sweats, cough with clear sputum, low grade fever. On 20 Feb 2025, she presented for Nucala inj. She was feeling better after antibiotics. She still had residual cough. On 20 Mar 2025, she presented for Nucala inj. She was slowly getting better but still having coughing fits twice a day. On 17 Apr 2025, she presented for Nucala inj. She had residual cough otherwise doing okay. On 15 May 2025, she presented for Nucala. She had no complaints and doing well. On 12 Jun 2025, she presented for Nucala inj. She had sinus infection otherwise doing okay. She reported diminished activity and fatigue but reported no excess weight gain, no excess weight loss, no loss of appetite, no fever, and not fussy. She reports nasal discharge but reports no ear pain, no ear discharge, no hearing loss, no sinus pressure, no drooling, no swelling, no congestion, no sore throat, no hoarseness, no mouth lesions, no foul smelling breath, sneezing, no runny nose, and not constantly clearing the throat. She reported coughing up sputum and clear sputum but repots Wheezing, no chest tighthess, no pain with respiration, normal breathing sounds, normal respiration rate, and no difficulty breathing. She reports sinus pressure but reports no itching. She reports no eye pain, no blurry vision, no eye redness, no eye itchiness, no eye swelling, and no eye discharge. She reports no chest pain, no rapid heart rate, no cyanosis, and no pallor. She reports no difficulty swallowing, no abdominal pain, no nausea, no vomiting, no diarrhea, no constipation, no blood in stools, no mucus in stools, and no regurgitation, water brash. She reports no discharge, no blood in urine, no pain during urination, no increased frequency of urination, and no voiding urgency. She reports no soft tissue swelling, no joint swelling, no limited motion, no previous injuries, and no myalgia. She reports no pain, no itchiness, no dry skin, no skin flaking, no skin redness, no rash, no diaper rash, no hives, no skin lesions, no swelling, no bruising, no insect bites, and no acanthosis nigricans. She reported no numbness, no weakness, no tingling, no burning, no shooting pain, no headache, no diziness, and no loss of consciousness. She reported no increased thirst and no temperature intolerance. She reports no depression, no sleep disturbances, feeling safe in relationship, and no alcohol abuse. She reported no swollen glands. On 09 Jan 2025, she went to ER for flu like symptoms and she was found to have bilateral pneumonia. She was discharged with levaquin. She was having increasing cough and unable sleep. She continued with Levaquin. She made aware of side effects such as tendinitis, Gl issues. She started medrol pak, continued with trelegy, add budesonide BID and alb nebs prn. She was slowly improving on levaquin. Stopped medrol due to insomnia. Using nebs. She was doing better initially with Levaquin initialby but now much more symptomatic. She had chest Xray on 27Jan 2025, Improving pneumonia. She was feeling better. She had chest Xray on 26 feb 2025, Improving LUL pulm infiltrate. She had asthma. Nucala inj given. She was doing okay with current regimen and denies any symptoms. Stop Breo/Spiriva and try Breztri. It was explained to her that Breztri was FDA approved for COPD. She was okay with trying this. It was advised the patient to rinse mouth after each use of innaler. It was advised to her the risks of oral thrush if she fails so. Talked to her regarding the side effects of the inhaler. She was agreeable to using it. Continued with Nucala for now and reevaluate in one month with spiro. On 24 Aug 2023, she was called office and did not want Breztri. On 20 Sep 2023, Nucala inj given, Lot TX7V, Exp 01/2026. She tolerated well and no reaction. Cont with Trelegy. On 18 Oct 2023, PFT looks better. Cont with current regimen. Nucala inj given, Lot TX7V, Exp Jan 2026. She tolerated well and no reaction. On 15 Nov 2023, Nucala ini given L ot XA2M Fxp Jan 2026 No reaction noted. Cont with current regimen. On 13 Dec 2023, Nucala injection given L posterior arm No incident Lot 2T7M Exp Feb 26. On 10 Jan 2024, Nucala inj given, Lot 8R7X, Exp 05/2026. Cont with Trelegy. On 07 Feb 2024, Nucala inj given, Lot 5R6S, Exp May 2026. Cont with current regimen. On 06 Mar 2024, Nucala inj given, Lot 8R7X, Exp May 2026. Cont with Trelegy. On 04 Apr 2024, She was on Nucala and Trelegy. She had been on Nucala for almost 3 years. felt her asthma was doing well with it. PFT with FEV1 56 percent with sig reversibility, FVC 56 percent with reversibility, FEF 25 to75 is 60% with sig reversibility, TLC 69 percent , RV 95 percent, DLco 104 percent of pred. Decline in spiro but pt reports she is doing well with current regimen, Trelegy and Nucala. Nucala inj given, Lot E97E, Exp 7/2026. Pt tolerated well. Repeat PFT in 3 months. On 02 May 2024, Nucala inj given, Lot E97E, Exp 07/2026. No reaction noted. Cont with Trelegy. On 30 May 2024, Nucala inj given, Lot HC8J, Exp 10/2026. Cont with Trelegy. On 27 Jun 2024, Nucala inj given, Lot HC8J, Exp 10/2026. Cont with Trelegy. PFT on 25 Jul 2024, FEV1 79 percent , FVC 72 percent/, FEF 25 to75 is 118 percent, TLC 67 percent , RV 66 percent , DLco 84percent of pred. On 25 Jul 2024, Nucala inj given, Lot M42L, Exp 11/2026. Cont with Trelegy. She was having physical therapy. She was doing well Spiro on 21 Aug 2024, FEV1 74 percent, FVC 66 percent, FEF 25 to75 is 133 percent of pred. On 21 Aug 2024, Nucala inj given, Lot R337, Exp 1/2027. Cont with Trelegy. She reported being in physical thera??/rsibility, TLC 85 percent, RV 113 percent, DLco 85 percent of pred. On 17 Oct 2024, PFT was stable. Cont with Trelegy and Nucala. On 14 Nov 2024, Nucala inj given, Lot UX7C, Exp 01/2027. Pt tolerated well. Cont with Trelegy. /Spiro on 23 Jan 2025, FEV1 56 percent, FVC 51 percent of pred. Decline in spiro due pneumonia. Nucala inj given, Lot UX7C, Exp 01/2027. Cont with trelegy/nucala and stop budesonide. Se had nausea from it. On 20 Feb 2025, Nucala inj given, Lot UX7C, Exp May 2027. Cont with trelegy/nucala. Pt had labs done with PCP. On 20 Mar 2025, Nucala inj given, Lot 558S, Exp May 2026 on L upper arm. Cont with treleay for now and start benzonatate for cough. On 17 Apr 2025, Nucala inj given, Lot UX7C, Exp May 2027. Cont with current regimen. She would like prednisone and zpak for travel. On 15 May 2025, Nucala inj given, Lot UX7C, Exp May 2027. Cont with trelegy. On 12 Jun 2025, Nucala inj given, Lot 5S6K, Exp Jul 2027. Schedule PFT for next visit. She had hx of chronic cough ongoing for several years. She had seen a Pulmonologist in to give us a copy of her records. She was currently on Pregablin. On 15 Sep 2020, she had a Methacholine challenge test on and its positive for asthma. Her cough was likely sec to asthma. On 26 Oct 2020, she was improving with breo. Still using Pregablin. She continued to have cough. She would like to refill the Pregablin. On 20 Dec 2020, she continued to be on Pregabalin BID. Asked her to cut back to qd as she was doing so much better. NO refills given. On 25 Feb 2021, she was still on the pregabalin. On 02 Mar 2021, she presented to the office for follow up. She reported persistent dry cough. She was currently on Breo 200/25 mcg, Spiriva, ProAir, and Singulair. Methacholine challenge test on 15 Sep 2020, and its positive for asthma. She denied any Fever, Chills, or CP. She was still on Pregabalin 25 mg. She was having coughing episodes 3x a day instead of all day. She was off of Pregabalin since Jan 2021. Cough was improving after Nucala injections, her coughing episodes was down to 2x a day now from 3x a day. She denied any SOB, Wheezing or CP. She started her nebs with some relief. She also scheduled to see a GI MD sometime in September. On 25 Aug 2021, she continued to be on Breo and Spiriva. On 12 Jan 2022, she stated her cough was better with current medications. On 14 Dec 2022, her cough resolved with current regimen. On 08 Mar 2023, she had a productive cough since December. On 28 Jun 2023, her cough had resolved. On 23 Aug 2023, she denied cough. On 25 Jul 2024, she had occ cough but doing okay. She had Multiple nodules of lung. She had CT chest in Jun 2017 showed 4 to 5mm nodules. She had not had a f/u CT done. Though she was a non smoker, the nodule was upper lobe location and hence needs a f/u. Onset date for right knee surgery was Jun 2023 and Orthopedic Surgery was 23 Jun 2023. Summary of changes: The event verbatim updated to Bilateral pneumonia. Events of Rhinorrhea, sinusitis, insomnia and nausea were added. Current conditions, allergies, Historical conditions and historical drugs added. Lab data added. Co-suspect, Concomitant and treatment drug added.; Sender's Comments: The company considers that there was no reasonable possibility that the events Pneumonia, knee operation and Orthopaedic procedure may have been caused by the Nucala drug, Nucala Pre filled Syringe Device, Arexvy vaccine and Shingrix vaccine.The Pneumonia is not listed in publicly available labelling for the study drug. There is an alternative etiology (medical procedure).
Alcohol use (occasional); Asthma (ER visit for asthma); Bronchitis; Chronic cough (for several years.); Drug allergy (Budosenide); Food allergy; Grass allergy; Hay fever; Multiple allergies; Pollen allergy; Seasonal allergic rhinitis; Sinusitis
Medical History/Concurrent Conditions: Appendectomy; Cataract operation; Knee injury (orthopedic surgery on 23-JUN-2023); Comments: Patient had animal exposure, patient was a nonsmoker and patient never used electronic cigarettes.
TRELEGY ELLIPTA; ALLEGRA ALLERGY; CALCIUM; MAGNESIUM; VITAMIN D3; Vitamin k2; XYZAL; AZITHROMYCIN; ALBUTEROL SULFATE HFA; AMOXICILLIN; POTASSIUM CLAVULANATE; BENZONATATE; DOXYCYCLINE HYCLATE; ERYTHROMYCIN; PREDNISONE; COVID-19 VACCINE; COVI
Test Date: 20230829; Test Name: Height; Result Unstructured Data: (Test Result:162,Unit:cm,Normal Low:,Normal High:); Test Date: 20250108; Test Name: chest X-ray; Result Unstructured Data: (Test Result:New bilateral airspace disease suspicious for pneu,Unit:unknown,Normal Low:,Normal High:) New bilateral airspace disease suspicious for pneumonia.; Test Date: 20250127; Test Name: chest X-ray; Result Unstructured Data: (Test Result:Improving pneumonia,Unit:unknown,Normal Low:,Normal High:); Test Date: 20250226; Test Name: chest X-ray; Result Unstructured Data: (Test Result:Improving Left Upper Lobe pulmonary infiltrate,Unit:unknown,Normal Low:,Normal High:); Test Date: 201706; Test Name: chest CT; Result Unstructured Data: (Test Result:4-5mm nodules,Unit:unknown,Normal Low:,Normal High:) 4-5mm nodules; Test Date: 20201007; Test Name: chest CT; Result Unstructured Data: (Test Result:Two 4 mm nodules in RLL,Unit:unknown,Normal Low:,Normal High:); Test Date: 20220215; Test Name: chest CT; Result Unstructured Data: (Test Result:Showed two stable 4mm RLL pulmonary nodules. Appea,Unit:unknown,Normal Low:,Normal High:) Showed two stable 4mm RLL pulmonary nodules. Appearing 3mm LLL pulmonary nodule.; Test Date: 20230222; Test Name: chest CT; Result Unstructured Data: (Test Result:Stable 4mm anterior RLL. Stable posterior RLL intr,Unit:unknown,Normal Low:,Normal High:) Stable 4mm anterior RLL. Stable posterior RLL intrapulmonary lymph node. Left periureteral intrapulmonary lymph node. Increased endobronchial opacity in the LLL which has increased in length while conforming to the bronchus.; Test Date: 20230816; Test Name: chest CT; Result Unstructured Data: (Test Result:stable 2 mm left lower lobe mucous plug, 4mm RLL p,Unit:unknown,Normal Low:,Normal High:) 4mm RLL pulmonary nodule is stable, improving endobronchial mucous plugging LLL.; Test Date: 20240807; Test Name: chest CT; Result Unstructured Data: (Test Result:stable 2 mm left lower lobe mucous plug, 4mm RLL p,Unit:unknown,Normal Low:,Normal High:) stable 2 mm left lower lobe mucous plug, 4mm RLL pulmonary nodule is stable, and 4mm left fissural nodule; Test Date: 20230829; Test Name: CBC; Result Unstructured Data: (Test Result:Rast panel are normal, ALPHA-1-ANTITRYPSIN PHENOTY,Unit:unknown,Normal Low:,Normal High:) Rast panel are normal, ALPHA-1-ANTITRYPSIN PHENOTYPE IS PIMM.; Test Date: 20230817; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:FEV1 40% with sig reversibility, FEF 25-75 is 30%,Unit:unknown,Normal Low:,Normal High:) FEV1 40% with sig reversibility, FEF 25-75 is 30% with sig reversibility, TLC 101%, RV 180%, DLco 85% of pred; Test Date: 20230823; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:shows decline which attributes to post sx and rece,Unit:unknown,Normal Low:,Normal High:) shows decline which attributes to post sx and recent wildfire; Test Date: 20240404; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:FEV1 56% with sig reversibility, FVC 56% with reve,Unit:unknown,Normal Low:,Normal High:) FEV1 56% with sig reversibility, FVC 56% with reversibility, FEF 25-75 is 60% with sig reversibility, TLC 69%, RV 95%, DLco 104% of pred; Test Date: 20240725; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:FEV1 79%, FVC 72%, FEF 25-75 is 118%, TLC 67%, RV,Unit:unknown,Normal Low:,Normal High:) FEV1 79%, FVC 72%, FEF 25-75 is 118%, TLC 67%, RV 66%, DLco 84% of pred.; Test Date: 20240821; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:FEV1 74%, FVC 66%, FEF 25-75 is 133% of pred,Unit:unknown,Normal Low:,Normal High:) FEV1 74%, FVC 66%, FEF 25-75 is 133% of pred; Test Date: 20241017; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:FEV1 75%, FVC 71%, FEF 25-75 is 96% with sig rever,Unit:unknown,Normal Low:,Normal High:) FEV1 75%, FVC 71%, FEF 25-75 is 96% with sig reversibility, TLC 85%, RV 113%, DLco 85% of pred.; Test Date: 20250123; Test Name: Pulmonary Function Test; Result Unstructured Data: (Test Result:FEV1 56%, FVC 51% of pred,Unit:unknown,Normal Low:,Normal High:) FEV1 56%, FVC 51% of pred; Test Date: 20230829; Test Name: weight; Result Unstructured Data: (Test Result:97,Unit:LB,Normal Low:,Normal High:)