Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Worsening cough; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4196758-00.  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 16Feb2021 (Lot number: EN9581) at the age of 69 years as dose 1, single for covid-19 immunisation; ibrutinib (IMBRUVICA), first regimen oral from 2015 (Batch/Lot number: unknown) to Nov2021 at 560 mg 1x/day (560 mg 1x/day) and second regimen oral since Dec2021 (ongoing) (Batch/Lot number: unknown) at 560 mg 1x/day (560 mg 1x/day) for lymphoma. Relevant medical history included: "Latex allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Cough" (ongoing); "No tobacco user" (unspecified if ongoing); "Abstain from alcohol" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "off label use", start date: 2015 (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Past drug history included: Pantoprazole for Indigestion. The following information was reported: COUGH (medically significant, life threatening) with onset 16Feb2021, outcome "not recovered", described as "Worsening cough". The action taken for ibrutinib was dosage not changed.  Clinical course: In 2015, the patient experienced Off Label Use. On 16Feb2021, the patient experienced Worsening Cough. In Nov2021, the patient experienced appendix almost burst. In Nov2021, the appendix almost burst resolved. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. In Nov2021 Patient reported that her appendix had removed due to the appendix was almost about to burst. She further stated that her COVID-19 vaccination was not related to her appendix almost bursting. She had stopped the use Imbruvica for two weeks for the documented appendix surgery. She was unable to provide the Associated manifestation for the allergy Latex. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Aspirin and Tylenol.  Causality for Imbruvica (Ibrutinib)  The reporter's causality for the event(s) of appendix almost burst and worsening cough with Imbruvica (Ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of off label use was not provided.   opinion is that there is no reasonable possibility that the events of appendix almost burst, off label use and worsening cough are related to Imbruvica (Ibrutinib).  Suspect Drug(S) Information  Suspect Drug(S) (include generic name)  Imbruvica (140 Milligram, Capsule) (Ibrutinib), Not Available,Not Available  Daily Dose:  560 mg (1 in 1 -2) 2) First dose. (1 -  Seq.No: 1  Drug: Imbruvica(140 Milligram, Capsule)(Ibrutinib)  DAILY DOSE:  1)560 mg (1 in 1 D)  2)560 mg (1 in 1 D)  Route of Administration:  1) Oral  2) Oral  Indications for Use: Non-Mantel Cell Lymphoma  Therapy Dates (From/To):  1) 2015 -Nov2021  2) Dec2021 - Ongoing  Causality  1). Appendix disorder  Action(s) taken with drug: Dose Not Changed  Outcome after reintro. of dose: Event did not reappear  Causality as per reporter (Drug/Vaccine): Not Related  Causality as per Mfr.(Drug/Vaccine): No reasonable possibility  Dechallenge: Yes  Rechallenge: Yes rechall, no recur  2) Off label use  Action(s) taken with drug: Dose Not Changed  Causality as per reporter (Drug/Vaccine): Not Reported  Causality as per Mfr.(Drug/Vaccine): No reasonable possibility  Dechallenge: N/A  3) Cough aggravated  Action(s) taken with drug: Dose Not Changed  Causality as per reporter (Drug/Vaccine): Not Relatable  Causality as per Mfr.(Drug/Vaccine): No reasonable possibility  Dechallenge: N/A  Suspect Drug(S) Information  Suspect Drug(S) (include generic name)  Indications For Use:  2) Covid-19 Vaccination  Seq.No.: 2  Drug: Pfizer Biontech Covid-19 Vaccine(Tozinameran)(Injection)(Tozinameran),EN9581, EN6208, EW0177  Daily Dose:  1 )First dose. (1 in 1 Once)  2) Second dose. (1 in 1 Once)  3) Third dose. (1 in 1 Once)  Route of Admin:  1) Intramuscular  2) Intramuscular  3) Intramuscular  Therapy Dates/Duration:  1) 01Feb2021 - 16Feb2021  2) 01Mar2021 - 01Mar2021  3) 20Aug2021 - 20Aug2021  Causality  1)Appendix disorder  Action(s) taken with drug: Not Applicable  Causality as per reporter (Drug/Vaccine): Not Related  Dechallenge: N/A  2) Off label use  Action(s) taken with drug: Not Applicable  Causality as per reporter (Drug/Vaccine): Not Reported  Dechallenge: N/A  2) Cough aggravated  Action(s) taken with drug: Not Applicable  Causality as per reporter (Drug/Vaccine): Possible  Dechallenge: N/A  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal association the possibility of causal association between the event Worsening cough and the suspect drug BNT162B2  cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.