Age: 73.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Angiogram, Cardiac function test, Dyspnoea, Off label use, Product use issue
Clinical narrative: Product use for unapproved combination; Off Label Use; breathing issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Oct2021 (Lot number: EW0187) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 11Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "severe asthma" (ongoing), notes: Diagnosed in childhood, as a child he had severe asthma but outgrew it and was fine for 60 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, lot: EK5730), administration date: 23Dec2020, when the patient was 73 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, lot: EK9231), administration date: 13Jan2021, when the patient was 73 years old, for Covid-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 11Oct2021, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 11Oct2021, outcome "unknown", described as "Off Label Use"; DYSPNOEA (non-serious) with onset Oct2021, outcome "not recovered", described as "breathing issues". The event "breathing issues" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyspnoea.  Additional Information: Caller was a consumer on behalf of her husband, she wanted to report an adverse reaction for the Pfizer-BioNTech COVID-19 vaccine (booster dose). Her husband is a 73 year old male patient who had received the first and second dose of the vaccine already. Patient received both Pfizer's vaccine (booster) and an unknown flu vaccine the same day. Since then, he has breathing issues, including severe asthma. Caller also said that her husband had asma as a child but he was cured and hadn't experienced any asma symptoms for 60 years. Caller stated that they have tried "a million treatments" and nothing has helped her husband. Caller wanted to know if we had any information on this adverse reaction that could help her husband. Other Products reported as no. Caller states she is calling to ask about the Pfizer Covid Booster vaccine and her husband who is the patient got all three Pfizer shots and he is a 73 year old doctor and as a child he had severe asthma but outgrew it and was fine for 60 years and after the Pfizer Covid booster shot all of a sudden had breathing issues in Oct2021 and now it is Feb and he has been to pulmonologists, cardiologists, allergists, thoracic surgeons and how is at the clinic and they cannot find anything to help him regarding his breathing issues and it was all triggered after the booster dose. States the patient can't talk to Pfizer because he can't breathe and demonstrated the patient's breathing on the line and states that nothing can help him and he has tried a million things like nebulizers, shots and has had all the new FDA approved medications and absolutely nothing gives him relief and it has been over 5 months.  Caller asks for information if Pfizer has heard this before or if Pfizer can help her or tell her anything that could help; aware Pfizer unable to offer treatment advice or medical recommendations. Caller states she just wants her husband to breathe. HCP information: Caller declined to provide any HCP information and states if needed she can send follow up questions to the HCP and the patient has so many HCPs. Caller states the patient's breathing issue is so much worse and they have done everything they can possibly do and just said there must be someone at Pfizer that they could talk to. Additional Vaccines Administered on Same Date of the Pfizer Suspect: Caller states the patient also had a flu vaccine administered in the other arm the same date as the Pfizer Booster vaccine but does not know the name of the flu vaccine, manufacturer or lot number. No AE(s) required to visit Emergency Room and Physician Office. Family Medical History Relevant to AE(s) reported as none. Relevant Tests: States he has had all things expected like pulmonary function tests, CT angiogram and a cardiac workup but has no specific dates or results to provide at this time. Caller was asked for the product names, lots, expiry dates or NDC numbers for any of the products the patient tried and did not work and declined to provide and states it has been over 5 months and her kitchen in her house looks like a pharmacy and she can't go through everything at this time. States the patient had childhood asthma and outgrew it and now has severe asthma now.  States the patient has been to 5 different specialists.  States the patient did not take any medications before the reported event but does now; no further details provided by the caller. Description of complaint: Treatment products, caller states that nothing can help him and he has tried a million things like nebulizers, shots and has had all the new FDA approved medications and absolutely nothing gives him relief.   Follow-up attempts are completed. No further information is expected.