Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Respiratory distress, Respiratory rate, SARS-CoV-2 test, Scan
Clinical narrative: They gave my husband and myself a bivalent vaccine. I called the CDC and they said I was positive for Covid; They gave my husband and myself a bivalent vaccine. I called the CDC and they said I was positive for Covid; I have been sick and deteriorating ever since I got the vaccine, the bivalent. I am in the hospital now; I have been sick and deteriorating ever since I got the vaccine, the bivalent. I am in the hospital now; Respiratory distress; pulmonary hypertension; I had 2 blood clots in the right lung; In the left lung they later found a blood clot; did a heart scan and found I didn't have cancer but I did have these masses. We thought, they must be granulomas; I can't walk; I am too weak; I have lost weight; I was a 180 Pounds but I am probably 170 now; get on my butt; I was hyponatremic; My PO4 was low; I was hyponatremic; My PO4 was low; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing); "smoke" (unspecified if ongoing); "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing), notes: COPD and exacerbation of COPD and prior to this on October; "tetanus" (unspecified if ongoing), notes: I had tetanus for dog bite like a 10 years ago. Concomitant medication(s) included: PNEUMOVAX taken for immunisation, on 02Oct2022 as dose number unknown, single; LORATADINE taken for hypersensitivity; BABY ASPIRIN. Past drug history included: Amlodipine. Vaccination history included: Tetanus (Prior vaccinations: Consumer stated, "No, 1957 is the last that we have tried tetanus.), administration date: 1957, for immunisation. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "They gave my husband and myself a bivalent vaccine. I called the CDC and they said I was positive for Covid"; CONDITION AGGRAVATED (hospitalization), ILLNESS (hospitalization), outcome "unknown" and all described as "I have been sick and deteriorating ever since I got the vaccine, the bivalent. I am in the hospital now"; RESPIRATORY DISTRESS (medically significant), outcome "unknown"; PULMONARY HYPERTENSION (medically significant), outcome "unknown"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "I had 2 blood clots in the right lung; In the left lung they later found a blood clot"; CARDIAC GRANULOMA (non-serious), outcome "unknown", described as "did a heart scan and found I didn't have cancer but I did have these masses. We thought, they must be granulomas"; GAIT INABILITY (non-serious), outcome "unknown", described as "I can't walk"; ASTHENIA (non-serious), outcome "unknown", described as "I am too weak"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "I have lost weight; I was a 180 Pounds but I am probably 170 now; get on my butt"; HYPONATRAEMIA (non-serious), HYPOPHOSPHATAEMIA (non-serious), outcome "unknown" and all described as "I was hyponatremic; My PO4 was low". The patient underwent the following laboratory tests and procedures: Blood phosphorus: (unspecified date) low; Blood pressure measurement: (unspecified date) Low, notes: My normal blood pressure once about a 100 over 50; Computerised tomogram: (unspecified date) found two masses, notes: She did a CT of my chest and found two masses; Full blood count: (unspecified date) Unknown results; (unspecified date) unknown; Heart rate: (unspecified date) under 70; Respiratory rate: (unspecified date) 18-20; SARS-CoV-2 test: (15Jul2022) Positive, notes: The first time I ever got Covid was 15Jul2022. The second time was after the vaccine again in 24Oct2022. I was positive both time for Covid never had it; (24Oct2022) Positive, notes: The first time I ever got Covid was 15Jul2022. The second time was after the vaccine again in 24Oct2022. I was positive both time for Covid never had it; Scan: (unspecified date) I didn't have cancer; Weight: (unspecified date) lost, notes: I have lost weight; I was a 180 Pounds but I am probably 170 now; get on my butt. Therapeutic measures were taken as a result of drug ineffective, covid-19, condition aggravated, illness, respiratory distress, pulmonary hypertension, pulmonary thrombosis, cardiac granuloma, gait inability, asthenia, hyponatraemia, hypophosphataemia.  Clinical course: when the patient received bivalent vaccine became sick that day and deteriorating ever since got the vaccine. The next day, called the CDC and they said I was positive for Covid.. The first time the patient ever got Covid was 15Jul2022. The second time was after the vaccine again in October 24Oct 2022. the was Hospitalized and have been in intensive care twice; received Heparin, Coumadin and Lovenox trying to get ready to go home. Also the patient could't walk, was too weak, have lost weight, was hyponatremic with PO4 low, had respiratory distress. Found out 2 blood clots in the right lung and one In the left lung. The patient had pulmonary hypertension (Lasix for the pulmonary hypertension) and a history of smoke, asthma, COPD and exacerbation of COPD and prior to this on October the. The patient did a CT of my chest and found two masses; did a heart scan and found but no cancer identified but did have these masses. They must be granulomas. Referred to a pulmonologist.The patient took inhalers as ANA Ativan and Albuterol a drug twice day, every 12 hours, NVTI of Symbicort twice a day another inhaler once a day.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the reported events  and the suspect drugBNT162B2 and  BNT162B2 OMI BA.4-5 BNT162B2 cannot be excluded. This case will be updated when more 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 AE. 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.