Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Inappropriate schedule of product administration, Interchange of vaccine products, Lung infiltration, Organising pneumonia
Clinical narrative: Acute hypoxic respiratory failure; Cryptogenic organizing pneumonia; Diffuse pulmonary infiltrates; Product = COVID 19/Administration date = 12Sep2022/ Dose number = 5; Other vaccine same date vaccine date = 12Sep2022/Other vaccine same date dose number = 4; inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years intramuscular, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "OSA" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: tape" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LYRICA; METFORMIN; PANTOPRAZOLE; FIORICET. Past drug history included: Diflucan, reaction(s): "Known allergies: Diflucan"; Reglan, reaction(s): "Known allergies: Reglan"; Singulair, reaction(s): "Known allergies: Singulair"; Sulfadiazine, reaction(s): "Known allergies: Sulfadiazine"; Ambien, reaction(s): "Known allergies: Ambien"; Zyrtec, reaction(s): "Known allergies: Zyrtec"; Biaxin, reaction(s): "Known allergies: Biaxin"; Demerol, reaction(s): "Known allergies: Demerol"; Morphine, reaction(s): "Known allergies: Morphine". Vaccination history included: BNT162b2 (Prev dose dose number = 4, Prev dose lot number = FK9893, Prev dose administrator route = Intramuscular, Prev dose administration date = 02Apr2022, Prev dose administration time = 11:00 AM, Prev dose vaccine location = Left arm), administration date: 02Apr2022, when the patient was 64-year-old, for COVID-19 immunization; moderna (Prev dose dose number = 3, Prev dose lot number = 058F21A, Prev dose administrator route = Intramuscular, Prev dose administration date = 03Nov2021, Prev dose administration time = 11:00 AM, Prev dose vaccine location = Left arm), administration date: 03Nov2021, when the patient was 64-year-old, for COVID-19 immunization; moderna (Prev dose dose number = 2, Prev dose lot number = 041B21A, Prev dose administrator route = Intramuscular, Prev dose administration date = 04Oct2021, Prev dose administration time = 11:00 AM, Prev dose vaccine location = Left arm), administration date: 04Oct2021, when the patient was 64-year-old, for COVID-19 immunization; moderna (Prev dose dose number = 1, Prev dose lot number = 011A21A, Prev dose administrator route = Intramuscular, Prev dose administration date = 11Mar2021, Prev dose administration time = 11:00 AM, Prev dose vaccine location = Left arm), administration date: 11Mar2021, when the patient was 63-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 12Sep2022, outcome "unknown", described as "Product = COVID 19/Administration date = 12Sep2022/ Dose number = 5; Other vaccine same date vaccine date = 12Sep2022/Other vaccine same date dose number = 4"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Sep2022, outcome "unknown", described as "inappropriate schedule of vaccine administered"; ACUTE RESPIRATORY FAILURE (hospitalization, life threatening) with onset 19Sep2022 at 07:00, outcome "not recovered", described as "Acute hypoxic respiratory failure"; ORGANISING PNEUMONIA (hospitalization, life threatening) with onset 19Sep2022 at 07:00, outcome "not recovered", described as "Cryptogenic organizing pneumonia"; LUNG INFILTRATION (hospitalization, life threatening) with onset 19Sep2022 at 07:00, outcome "not recovered", described as "Diffuse pulmonary infiltrates". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of acute respiratory failure, organising pneumonia, lung infiltration.; Sender's Comments: Given negative SARS-CoV-2 test, the reported serious events cryptogenic organizing pneumonia, Diffuse pulmonary infiltrates and Acute hypoxic respiratory failure represent concurrent medical conditions unrelated to the vaccine use.  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