Age: 57.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Heart rate, Influenza, Limb discomfort, Mitral valve incompetence, Oedema peripheral
Clinical narrative: AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH; COVID-19 and Pneumonia/COVID-19 pneumonia; COVID-19 and Pneumonia/COVID-19 pneumonia; Acute hypoxemic respiratory failure from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH; Pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus; Volume overload; Worsening MR (mitral regurgitation); Steroid induced diabetes; Lower extremity edema, 2+ pitting edema, to knees. 1+ dependent edema at thighs; Weight slowly coming down, weight up 4 lbs; Rash; Diarrhea; leg healing (limb discomfort); Fever, temperature 101.1 F; This is a solicited report received from a non-contactable other health care professional via pharmacy. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 24Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation, nifedipine, oral from an unspecified date at unspecified dose for hypertension, methylprednisolone (MEDROL, tablet), oral from an unspecified date at 16 mg, daily (every evening), and oral from an unspecified date at 1.5 DF, daily for an unspecified indication, and treprostinil diolamin (ORENITRAM), oral from 01Aug2019 at unspecified dose, oral from an unspecified date (Lot Number: 2101647; Expiration Date: 30Jan2022) at 3.875 mg, 3x/day (q8h),  oral from an unspecified date (Lot Number: 2101648; Expiration Date: 31Jan2022) at 3 mg, 3x/day (q8h), oral from an unspecified date (Lot Number: 2101649; Expiration Date: 31Jan2022) at 2.875 mg, 3x/day (q8h),  oral from an unspecified date (Lot Number: 2101646; Expiration Date: 31Jan2022) at unspecified dose, and oral from an unspecified date (Lot Number: 2101810; Expiration Date: 31Jan2023) at unspecified dose for Primary Pulmonary arterial hypertension. The patient's medical history ongoing Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), ongoing Systemic lupus erythematosus, ongoing Sleep apnoea syndrome (obstructive sleep apnea (OSA) on Continuous positive airway pressure (CPAP)), ongoing Hypercalcaemia, ongoing Peripheral arterial occlusive disease, ongoing Dyspnoea, family history of COVID-19 (Brother positive), ongoing Continuous positive airway pressure, and ongoing Hypertension. The patient's concomitant medications included ambrisentan (LETAIRIS), sildenafil citrate (REVATIO), calcium citrate, ergocalciferol (CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]), digoxin (LANOXIN), epinephrine (EPIPEN), escitalopram oxalate (LEXAPRO), folic acid (FOLVITE [FOLIC ACID]), hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); all ongoing, famotidine (PEPCID [FAMOTIDINE]) from an unspecified start date to Apr2021, furosemide (LASIX [FUROSEMIDE]) from an unspecified start date to Apr2021, spironolactone (ALDACTONE [SPIRONOLACTONE from an unspecified start date to Apr2021, and apixaban (ELIQUIS).  On 23Mar2021, the patient experienced COVID-19 and pneumonia (COVID-19 pneumonia). The patient was hospitalized on 23Mar2021.  The patient was on oxygen at the time of reporting. On 06Apr2021, the patient had pneumonia. The patient was hospitalized due to pneumonia and remained hospitalized at the time of reporting. The patient clarified it as COVID-19 pneumonia. Since 06Apr2021, the patient remained hospitalized due to COVID-19 pneumonia. On 16Apr2021, the patient had acute hypoxemic respiratory failure (AHRF) from COVID, AHRF secondary to Influenza B exacerbating PAH (pulmonary arterial hypertension), AHRF secondary to Flu B and PAH with baseline PAH,  Pulmonary hypertension (pHTN) exacerbation, AHRF (acute hypoxemic respiratory failure) secondary to influenza B exacerbating PAH, pHTN treated with steroids as though to be flare due to lupus, AHRF secondary to Flu B and PAH with baseline PAH, volume overload. The patient was hospitalized due to the events on 16Apr2021 to 26Apr2021. The patient was presented with volume overload and needed oxygen requirement (none needed at home prior to both hospitalizations). The patient's breathing and oxygen were improved with diuresis.  The patient was treated with steroids as though to be flare due to lupus. Patient was given intravenous (IV) solumedrol (25 mg in AM and 16 mg in PM) as per the discussion with rheumatology and pulmonary hypertension cardiology with improvement in oxygen status. On 24Apr2021, the patient relevant diagnostic and laboratory test included: WBC (white blood count) 4.79, RBC (Red blood cell count) 3.31, Hgb (hemoglobin) 8.4, Plt (Platelet count) 146. Comprehensive metabolic panel (CMP) Na (sodium) 141, K (potassium) 4.1, Blood urea nitrogen (BUN) 39, Creatinine 1.68, glucose 90. On 25Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.51, RBC 3.24, Hgb 8.2, Plt 159. Na 141, K 4.4, BUN 39, Creatinine 1.59, glucose 117. On 26Apr2021, the patient had relevant diagnostic and laboratory test included WBC 5.41, RBC 3.30, hgb 8.3, Plt 159. Na 141, K 4.4, BUN 37, creatinine 1.54, and glucose 90. The patient was discharged on 26Apr2021.  Patient's physical exam at the time of discharge showed pulse 65 bpm, respiratory rate 18 per minute, blood pressure (BP) 138/78 mmHg, temperature 36.5 C and weight was 90.9 kg. The patient was breathing comfortably in no distress on 2 Litre nasal cannula (NC). Minimal crackles appreciated in the morning posteriorly. The patient had 2+ pitting edema, to knees 1+ dependent edema at thighs and edema unchanged but overall leg size decreased. Continues to be pitting but improved on the day of discharge. Patient's discharge diagnosis pulmonary hypertension exacerbation. Patient's diuretics were increased from 40 mg daily to 60 mg daily and may needed more diuretics. Discharge medications included: Protonix (pantoprazole), Demadex (torsemide), Medrol (methylprednisolone), Citracal + d (calcium citrate, ergocalciferol), Lanoxin (digoxin), EpiPen (epinephrine), Lexapro (escitalopram oxalate), Folvite (folic acid), Plaquenil (hydroxychloroquine sulfate). Patient's medications of Pepcid, Lasix, and Aldactone were stopped after discharge from the hospital. The patient was instructed to take pantoprazole 40 mg daily while on steroids and when steroids tapered, he had to discontinue it in future and would stop pantoprazole and resume taking home dose of famotidine. Patient was on nifedipine at home and physician thought to be the contributing factor to lower extremity edema so stopped taking the nifedipine in house. It was reported that steroid induced the diabetes. It was reported that the patient needs transesophageal echocardiogram (TEE) due to had worsening MR (mitral regurgitation) but not agreeable at that time. The patient tried ethacrynic acid 50 mg daily but felt it was not making a difference with his weight. The patient went back on the Bumex (bumetanide) on Friday. Patient's weight slowly coming down to see doing good later on Bumex, his rash subsiding and leg was healing. Patient's weight was stable at 155 lbs and had multifactorial stable shortness of breath (SOB). Patient's weight was above baseline and needed more diuretics. Patient had been in touch with his COVID positive brother who was symptomatic and refused to be covid testing quarantining at that time. In 2021, the patient got his first dose of COVID-19 vaccine and his temperature was 101.1 F. The patient would take Tylenol (paracetamol) and monitor if fever persists to 48 hours he would go to the urgent care. Patient was started on Eliquis and felt much better and no longer to had temperatures and diarrhea. On an 21Apr2021, the patient had right heart catheterization which revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, ci 3.52. Patient had chronically high PAD's and could not take metolazone secondary to hypercalcemia and pending admission for colonoscopy with the physician. Patient reminded multiple times by physician for getting a COVID swab. The patient also had increased 4 lb weight since discharge from the hospital. In 2021, the patient experienced had fever, temperature 101.1 F. On an unknown date, the patient experienced had worsening MR (mitral regurgitation), steroid induced diabetes, lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at thighs, weight slowly coming down, weight up 4 lbs, rash, diarrhea, and leg healing (limb discomfort). In 2021, patient weight was up by 4 lbs since discharge from hospital. The action for nifedipine in response to the events was unknown. The action for methylprednisolone in response to the events was unknown. The action for treprostinil diolamin in response to the events was unknown. The outcome of the events COVID-19 pneumonia, drug ineffective, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation was unknown. The outcome of the events rash and limb discomfort was recovering. The outcome of the events pyrexia and diarrhoea was recovered on an unknown date in 2021.  Case Comment/Senders Comment: The company has assessed the serious adverse events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, and steroid diabetes as not related to Orenitram. The event of COVID-19 pneumonia was related to the ongoing SARS-CoV-2 pandemic, and the event influenza was related to seasonal Influenza B. The event acute respiratory failure was likely related to acute influenza, but was also possibly impacted by pulmonary insult from COVID-19 pneumonia , and underlying lupus associated with PAH. The event pulmonary arterial hypertension was likely an exacerbation of the underlying PAH due to the concurrent infections. The event mitral valve incompetence and fluid overload were likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event steroid diabetes was likely related to co-suspect medication Medrol, which was used as treatment for the lupus, although co-suspect medication nifedipine was possibly contributory to the event in view of its safety profile and as such cannot be excluded.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, events of COVID-19 pneumonia, Drug ineffective, Fever, Diarrhea could be related to the suspected drug of BNT162B2. All the other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug.  The reported events are considered unlikely related to the suspected drug of Nifedipine.  The events of Diabetes steroid-induced is most likely related to co-suspect medication Medrol, which was used as treatment for the lupus. All the other events are considered unlikely related to the suspected drug of Medrol.   Medical history of ongoing Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), ongoing Systemic lupus erythematosus, and ongoing Dyspnoea may provide explanations for some of the events (such as Pulmonary arterial hypertension, Volume overload, Mitral regurgitation, and Oedema peripheral).   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.