Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: deltoid soreness; swallowing was so difficulty in Aug2022; bleeding in lungs; epiglottitis; he had pretty bad hemoptysis/He had hard productive cough and bright red blood productive cough that lasted for 2 weeks; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2022 as dose 4 (booster), single (Lot number: FS6869) at the age of 70 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "COVID", start date: Feb2020, stop date: Feb2020, notes: Covid was first hitting the news in Feb2020; "immune system abnormality" (unspecified if ongoing), notes: has primary immune system abnormality that is congenital; "sinopulmonary infections" (unspecified if ongoing); "bronchiectasis" (unspecified if ongoing), notes: in right middle lobe and left lower lobe.; "IGA deficient" (unspecified if ongoing); "IgG monoclonal gammopathy" (unspecified if ongoing); "immuno system compromise" (unspecified if ongoing); "arthritic" (unspecified if ongoing); "pulmonary system compromise" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: EY0584), administration date: 16Aug2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "Deltoid soreness"; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6204), administration date: 11Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Deltoid soreness"; BNT162b2 (DOSE 1, SINGLE; Lot number: EL9265), administration date: 18Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Deltoid soreness"; flu high dose vaccination (DOSE 3, SINGLE), administration date: 27Sep2021, when the patient was 70-year-old, for Influenza Immunization; flu high dose vaccination (DOSE 2, SINGLE), administration date: 16Sep2020, when the patient was 69-year-old, for Influenza Immunization; flu high dose vaccination (DOSE 1, SINGLE), administration date: 14Oct2019, when the patient was 68-year-old, for Influenza Immunization; pneumococcal conjugate 23, administration date: 27Sep2021, when the patient was 70-year-old, for Pneumococcal Immunization; pneumococcal polysaccharide ppsv 13, administration date: 20May2015, when the patient was 64-year-old, for Pneumococcal Immunization; measles mumps rubella (He also had MMR, Measles Mumps Rubella, on 16Sep2013), administration date: 16Sep2013, when the patient was 62-year-old, for Immunization. The following information was reported: PULMONARY HAEMORRHAGE (medically significant) with onset Aug2022, outcome "unknown", described as "bleeding in lungs"; EPIGLOTTITIS (medically significant) with onset Aug2022, outcome "unknown"; HAEMOPTYSIS (medically significant) with onset Aug2022, outcome "unknown", described as "he had pretty bad hemoptysis/He had hard productive cough and bright red blood productive cough that lasted for 2 weeks"; DYSPHAGIA (non-serious) with onset Aug2022, outcome "unknown", described as "swallowing was so difficulty in Aug2022"; MYALGIA (non-serious), outcome "unknown", described as "deltoid soreness". The events "bleeding in lungs", "epiglottitis", "he had pretty bad hemoptysis/he had hard productive cough and bright red blood productive cough that lasted for 2 weeks" and "swallowing was so difficulty in aug2022" required physician office visit.  Clinical course: Caller is a retired cranial facial surgeon. He trained at (Place withheld). He has a pretty crummy immune system. He is 100% IGA deficient. He has IgG monoclonal gammopathy. As soon as the Covid vaccine came out he got it because he has sinopulmonary infections and always gets his annual flu shot. He does have a question about the upcoming RSV vaccine. He is prone to acute and chronic bronchitic infections. He has gotten all the Pfizer Covid vaccine in succession as they have been released. He has read stuff in medical literature that raised concern about the exact methodology that manufactures Covid mRNA vaccine that caught his attention. Specifically concerned that in the literature Pfizer allegedly is using modified RNA. If they are and if an mRNA at 6 days is modified, the question arose dose this jeopardize the patient's or recipient's DNA especially neurodegenerative.  Caller is (Withheld) that Glaxo has released RSV vaccine. Caller wants to remain with Pfizer products since he has had the whole battery of Covid vaccines manufactured by Pfizer. With each injection of Covid vaccine he had localized deltoid soreness for a day or a day and half. He had no remarkable reaction in the series. Currently he is 72 and started receiving vaccines 3 years ago. He was 69 at the time of the initial injection. He had follow up dose being he was over age 65 and having pulmonary and immuno system compromise. He got the booster on 14Oct2022 at a (Pharmacy Withheld), LOT: GJ26234, NDC: unknown, EXP: unknown. Because of EG5 and BA286 he is planning to get a 6th Covid injection when it comes available in September. He is over age 65 and that puts him at risk and has primary immune system abnormality that is congenital and gets a lot of sinopulmonary infections. He sees pulmonologist and has had cat scan documented evidence of bronchiectasis in right middle lobe and left lower lobe. Despite all this and masking and isolating and being careful and his wife is careful and also fully vaccinated, caller has had Covid twice. aller had first episode of Covid when Covid was first hitting the news in Feb2020. Then he had a more severe episode of Covid with epiglottitis that was particularly nasty because swallowing was so difficulty in Aug2022. What prompted caller to see pulmonologist was in the Aug2022 Covid experience he had pretty bad hemoptysis. He had hard productive cough and bright red blood productive cough that lasted for 2 weeks. He is fortunate of surviving that episode of Covid. Given his age and pulmonary history dumping Covid on top with bleeding in lungs and epiglottitis.He has host of medical issues primarily arthritic. They are unrelated. The only time he had had deltoid soreness was with Covid vaccine or annual flu shot or pneumonia vax. It was transient and temporary. Caller clarified that he doesn't know the manufacturers of the flu shots he has had or the pneumonia vaccines. That gets to be too much to remember.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported events 'Pulmonary hemorrhage', 'epiglottitis' and 'hemoptysis',due to a plausible temporal association.The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.,Linked Report(s) : US-PFIZER INC-202300288361 same reporter/patient, different doses/AE;