Sex: U
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Hyperventilation, SARS-CoV-2 antibody test
Clinical narrative: short of breath fully as of going to faint/developed profound CHF; Hyperventilation; This is a spontaneous report received from a Nurse.  A 75-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9693) intramuscular for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CITRACAL [CALCIUM CITRATE] oral (ongoing). The patient also took other concomitant therapy. Vaccination history included: BNT162b2 (DOSE 1, Lot EJL685), administration date: 22Dec2020, for COVID-19 immunization, reaction(s): "her arm was sore", "she felt tired", "achy", "Arm blew up like a baseball: This diminished over the 1st and was hardly noticeable, by the 2nd it was gone."; BNT162b2 (DOSE 2, Lot EL3248), administration date: 12Jan2021, for COVID-19 immunization, reaction(s): "her arm was sore", "she felt tired", "achy", "Arm blew up like a baseball: This diminished over the 1st and was hardly noticeable, by the 2nd it was gone."; BNT162b2 (DOSE 3 (BOOSTER), Lot EW0185), administration date: 30Sep2021, for COVID-19 immunization, reaction(s): "severe CHF", "Nauseous", "sudden SOB/difficulty breathing/ Dyspnoea", "Hyperventilation", "feeling of fainting", "wheezy feeling", "achy/aching/Arm blew up like a baseball", "headache", "No appetite", "sore arm", "not feeling well (flu like)", "not feeling well (flu like)", "swollen arm", "not feeling for 2 days", "she felt a little tired", "She can hardly lift her head to the pillow"; BNT162b2 (DOSE 4 (BOOSTER), Lot FP7135), administration date: 25Jun2022, for COVID-19 immunization. The following information was reported: CARDIAC FAILURE CONGESTIVE (hospitalization, medically significant), outcome "unknown", described as "short of breath fully as of going to faint/developed profound CHF"; HYPERVENTILATION (hospitalization), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: -. Therapeutic measures were taken as a result of cardiac failure congestive. Clinical course: Got 2nd booster(dose 5 reported as 2nd booster by reporter) to dose 6(Last noted booster 2024 Not taken), Patient had profound event short of breath fully as of going to faint, hyperventilation called help and done a Covid test which was (-), within couple months developed profound CHF requiring Hospitalization placement of pacer/ICD(+). Last Booster cause Profine Health effects.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cardiac failure congestive, hyperventilation and the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202101325900 same patient/patient/drug, different dose/event;US-PFIZER INC-202101327766 same patient/patient/drug, different dose/event;