Received Jun 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUN4 | INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) | MEDIMMUNE VACCINES, INC. | UNK | — | — |
prostate cancer; loss weight, has dropped 4 pounds; shortness of breath; chest tightness; cough, intermittent coughing, increasing coughing; wheezing, wheezing throughout, intermitent wheeze; mobility is severely limited; Dyspnea on exertion, lingering dyspnea on exertion; Morbid obesity, obesity; occasional congestion, some nasal congestion; persisting leg wound; air trapping; decreased diffusing capacity; arthritis; chronic rhinitis; coughing now productive of green phlegm, cough with phlegm; decreased FEV1 and FVC with marginal bronchodilator response; skin is dry; worse after he lies down/if misses dose of Symbicort significantly worse; never heard back from pharmacy on obtaining Tezspire so he has not gotten any further injections, still not on regular Tezspire; A solicited report has been received from a physician in Patient Support Program concerning a male patient. No medical history was reported. Concomitant medication included Folvite (since 02-DEC-2012), Toprol Xl (since 30-MAY-2017), Kevzara (since 05-AUG-2018), Trelegy Ellipta (since 08-JAN-2024), Albuterol for chest tightness, shortness of breath and wheezing (since 29-JAN-2024), Prednisone (from MAR-2024 to JUL-2024), Loniten (since 10-MAY-2024), Benicar (since 09-JUL-2024), Flonase (since 24-AUG-2024), Cipro (since 09-SEP-2024), Albuterol Hfa (since 29-OCT-2024), Singulair (since 31-OCT-2024), Sarilumab, Doxycycline, Percocet, Mobic for rheumatoid arthritis, Azulfidine and Xopenex. During 2019, the patient started treatment with Symbicort (budesonide, formoterol) 160 milligram bid. During OCT-2021, the patient started treatment with Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv (flumist, influenza virus vaccine polyvalent, q/laiv) UNK. On 25-JUN-2024, the patient started treatment with Airsupra (budesonide, albuterol) unknown dose, q4h, Inhalation use. During JUL-2024, the patient started treatment with Tezepelumab (tezepelumab) 210 milligram q4w, Subcutaneous use, for asthma. It is unknown who administered Airsupra, Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv, Symbicort, Tezepelumab to the patient. During 15-JUN-19, the patient experienced prostate cancer (preferred term: Prostate cancer). During 15-JAN-24, the patient experienced dyspnea on exertion, lingering dyspnea on exertion (preferred term: Dyspnoea exertional), wheezing, wheezing throughout, intermitent wheeze (preferred term: Wheezing), cough, intermittent coughing, increasing coughing (preferred term: Cough) and occasional congestion, some nasal congestion (preferred term: Nasal congestion). During 15-MAR-24, the patient experienced coughing now productive of green phlegm, cough with phlegm (preferred term: Productive cough). On an unknown date, the patient experienced loss weight, has dropped 4 pounds (preferred term: Weight decreased), decreased diffusing capacity (preferred term: Total lung capacity abnormal), air trapping (preferred term: Obstructive airways disorder), persisting leg wound (preferred term: Limb injury), shortness of breath (preferred term: Dyspnoea), chest tightness (preferred term: Chest discomfort), chronic rhinitis (preferred term: Rhinitis), skin is dry (preferred term: Dry skin), decreased fev1 and fvc with marginal bronchodilator response (preferred term: FEV1/FVC ratio decreased), morbid obesity, obesity (preferred term: Obesity), arthritis (preferred term: Arthritis), severe mobility is severely limited (preferred term: Mobility decreased) and worse after he lies down/if misses dose of symbicort significantly worse (preferred term: Condition aggravated). The report described a medication error for Tezepelumab. The reported term was never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire (preferred term: Product dose omission issue). The dose of Airsupra (budesonide, albuterol) and Tezepelumab (tezepelumab) was not changed. Treatment with Symbicort (budesonide, formoterol) was discontinued during MAR-2024. At the time of reporting, the event decreased diffusing capacity was improving. The outcome of the event(s) of air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse was unknown. The following event(s) were considered serious due to medically significant:prostate cancer. The following events were considered non-serious:air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The reporter did not assess causality for air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, prostate cancer, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Airsupra and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Evocap Metered Dose Inhaler and the following event(s): air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Evocapxs Metered Dose Inhaler and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, prostate cancer, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Symbicort and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Tezepelumab and the following event(s): air trapping, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, shortness of breath, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician did not consider that there was a reasonable possibility of a causal relationship between Ypsomate Automatic Injector and the following event(s): air trapping, arthritis, chest tightness, chronic rhinitis, cough, intermittent coughing, increasing coughing, coughing now productive of green phlegm, cough with phlegm, decreased diffusing capacity, decreased fev1 and fvc with marginal bronchodilator response, dyspnea on exertion, lingering dyspnea on exertion, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, never heard back from pharmacy on obtaining tezspire so he has not gotten any further injections, still not on regular tezspire, occasional congestion, some nasal congestion, persisting leg wound, prostate cancer, shortness of breath, skin is dry, wheezing, wheezing throughout, intermitent wheeze and worse after he lies down/if misses dose of symbicort significantly worse. The company physician considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Airsupra and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Evocapxs Metered Dose Inhaler and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Symbicort and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. The company physician considered that there was a reasonable possibility of a causal relationship between Tezepelumab and the following event(s): arthritis, loss weight, has dropped 4 pounds, mobility is severely limited, morbid obesity, obesity, persisting leg wound, prostate cancer and skin is dry. Laboratory values are available. Device Information: Combination Product Report: Yes Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Product As Reported: Symbicort Brand Name: SYMBICORT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No All required follow-up attempts have been completed to obtain the Lot / Batch number for Symbicort, Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv, Airsupra and Tezepelumab, however the Lot / Batch number was not received. Summary of follow-up information received by AstraZeneca/MedImmune from physician via solicited source on 02-Dec-2024: new suspects (Symbicort, Airsupra, Influenza vaccine) and concomitant drugs added, new serious event of prostate cancer added, non-serious events of loss weight, has dropped 4 pounds, mobility is severely limited, dyspnea on exertion, lingering dyspnea on exertion, morbid obesity, occasional congestion, some nasal congestion, arthritis, chronic rhinitis, coughing now productive of green phlegm, cough with plegm, worse after he lies down, decreased FEV1 and FVC with marginal bronchodilator response, skin is dry, if misses dose of Symbicort significantly worse, never heard back from pharmacy on obtaining Tezspire so he has not gotten any further injections, still not on regular Tezspire added, outcome for the event of new serious event of Total lung capacity abnormal was updated to recovering, start date for the events of cough, wheezing added, patient's gender, relevant histories and lab test added, start date of Tezspire was updated to Jul-2024 from Sep-2024, frequency added as q4w, patient's allergies added, narrative was updated. Minor correction on 09-Dec-2024: ethnic group was updated to no information from unknown, batch information on Tezspire corrected. Summary of follow-up information received by AstraZeneca on 02-Jan-2025 from marketing company: Summary of unsuccessful Lot/Batch number attempts added. Event never heard back from pharmacy on obtaining Tezspire so he has not gotten any further injections, still not on regular Tezspire recoded. Event verbatim updated to worse after he lies down/if misses dose of Symbicort significantly worse. Updated lot number as ASKU. Narrative updated. Corrected report on 29-Apr-2025: Recoding of suspect flumist, influenza virus vaccine polyvalent, q/laiv and device was added for the same. Narrative amended. Summary of follow-up information received by AstraZeneca on 22-May-2025 from Marketing company: Summary of unsuccessful Lot/Batch number attempts added. Narrative updated.; Sender's Comments: Prostate cancer is not listed in the core data sheet of Tezepelumab, Budesonide, formoterol, Flumist, Influenza virus vaccine polyvalent, Q/LAIV and Budesonide, albuterol. Due to limited information on underlying comorbidities, past medical history and concomitant medications, complete etiologic and diagnostic workup the evaluation did not find evidence to exclude a reasonable possibility of a causal relationship between Event and suspect drugs.
Medical History/Concurrent Conditions: Asthma; Chest tightness; Penicillin allergy; Rheumatoid arthritis; Shortness of breath; Topical adhesive allergy; Wheezing
Albuterol; Albuterol Hfa; Azulfidine; Benicar; Cipro; Doxycycline; Folvite; Flonase; Kevzara; Loniten; Mobic; Percocet; Prednisone; Sarilumab; Singulair; Toprol xl; Trelegy ellipta; Xopenex; TEZEPELUMAB; SYMBICORT; AIRSUPRA
Test Date: 2024; Test Name: OXIMETRY; Test Result: 93 %; Test Date: 202406; Test Name: OXIMETRY; Test Result: 94 %