Age: 57.0
Sex: M
Vaccine: COVID19, UNK, UNK, UNK, COVID19, UNK, UNK, UNK
Symptoms: Mitral valve incompetence, Oedema peripheral, PO2, Platelet count, Pulmonary arterial hypertension
Clinical narrative: This is a solicited report based on the information received by Pfizer (Mfr Report# UNT-2021-005860).  A contactable consumer (patient) reported a 57-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number and Expiration Date unknown) via an unspecified route of administration on 24Feb2021 as age of 57 years old at 1ST DOSE, SINGLE for COVID-19 immunization. Co-suspect medications included: nifedipine via an unspecified route of administration from an unknown date at an unspecified dose, frequency and for hypertension; methylprednisolone (MEDROL, Tablet) orally from an unknown date at 16mg daily and for lupus; treprostinil diethanolamine (ORENITRAM, Extended release tablet) orally (PO) from 01Aug2019 at unknow dose and frequency; orally from unknown date at 3.875mg, every eight hours (q8h);(Lot: 2101647 and Expiration date:30Jan2022) at 0.25mg unknown frequency; (Lot: 2101648 and Expiration date: 31Jan2022) orally from unknown date at unknow dose and frequency; (Lot: 2101649 and Expiration date: 31Jan2022) orally from unknown date at 2.875mg, 3x/day; (Lot: 2101810 and Expiration date: 31Jan2023) orally from unknown date at 0.125 mg unknown frequency;(Lot: 2101646 and Expiration date: 31Jan2022) orally from unknown date at unknown dose and frequency; orally from unknown date and ongoing at 3mg 3x/day; all for primary pulmonary arterial hypertension. Relevant ongoing medical history included primary pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation), calcium deficiency, systemic lupus erythematosus (SLE), obstructive sleep apnea (OSA) on Continuous positive airway pressure (CPAP), hypercalcemia, chronically high peripheral artery disease (PAD), hypertension and multifactorial stable SOB (shortness of breath). Patient's family history included: COVID-19 (brother positive). Concomitant medications included ambrisentan (LETAIRIS), spironolactone (ALDACTONE), calcium citrate, ergocalciferol (CITRACAL + D), apixaban (ELIQUIS), epinephrine (EPIPEN), folic acid (FOLVITE), digoxin (LANOXIN), furosemide (LASIX), escitalopram oxalate (LEXAPRO), famotidine (PEPCID), hydroxychloroquine sulfate (PLAQUENIL), and sildenafil citrate (REVATIO). This is a solicited report received on 31Mar2021 from a consumer via (pharmacy name). Patient began therapy with Orenitram (treprostinil diethanolamine), on 01 Aug 2019 for primary pulmonary arterial hypertension. The patient was supplied with Orenitram 0.25mg, 1mg, 2.5mg and 0.125mg and the current dose was reported as 3.875mg, via oral (PO) route, every eight hours (q8h). On 23Mar2021, the patient experienced event COVID-19 and pneumonia (COVID-19 pneumonia, hospitalization, medically significant).On 23Mar2021, 1 year 7 months 23 days after initiating PO Orenitram, the patient was hospitalized due to COVID-19 and pneumonia and discharged on 29 Mar 2021. The patient was on oxygen at the time of reporting. Action taken with PO Orenitram dose for the event of COVID-19 pneumonia was not reported. At the time of reporting, the outcome of the event of COVID-19 pneumonia was unknown.The reporter did not provide causality for the event of COVID-19 pneumonia. Follow-up information was received as solicited report on 15Apr2021 from a consumer via (pharmacy name). On 06Apr2021, the patient had pneumonia (pneumonia, medically significant and hospitalized). Additional lot number and expiration date were added to 2.5 mg concentration of PO Orenitram. On 06Apr2021, 1 year 8 months 6 days after initiating PO Orenitram, the patient was hospitalized due to pneumonia and remained hospitalized at the time of reporting. The patient was also hospitalized in Mar2021 for COVID (previously reported COVID-19 pneumonia). Action taken with PO Orenitram dose for the event of pneumonia was not reported. At the time of reporting, the outcome of the event of pneumonia was unknown. The reporter did not provide causality for the event of pneumonia. Additional spontaneous information was received on 19Apr2021 from a consumer (social worker) via (pharmacy name). Event of pneumonia was omitted and subsumed under COVID-19 pneumonia. Since 06Apr2021, the patient remained hospitalized due to COVID (previously reported COVID-19 pneumonia). Follow-up information was received on 27Apr2021, from a nurse on behalf of the reporting physician via a query response. 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 (acute respiratory failure, hospitalized, medically significant), 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 (pulmonary arterial hypertension, hospitalized and medically significant), AHRF secondary to Flu B and PAH with baseline PAH (influenza, hospitalized), volume overload (fluid overload, hospitalized). On an unreported date in 2021, the patient had fever, temperature 101.1 F (pyrexia). On an unreported date, the patient had worsening MR (mitral regurgitation) (mitral valve incompetence, medically significant), steroid induced diabetes (steroid diabetes, medically significant), lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at thighs (oedema peripheral), weight slowly coming down, weight up 4 lbs (weight fluctuation), rash (rash), diarrhea (diarrhoea), and leg healing (limb discomfort). On 16Apr2021, 1 year 8 months 16 days after initiating PO Orenitram, the patient was hospitalised due to acute hypoxemic respiratory failure (AHRF) from COVID (previously reported COVID-19 pneumonia) and for AHRF secondary to influenza B exacerbating PAH, then transferred to the other hospital with volume overload and diuresis. 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. Patient's pulmonary hypertension 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: complete blood count (CBC) 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. On 24Feb2021, the patient got his first dose of COVID-19 vaccine and his temperature was 101.1 °F in 2021. 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-19 swab. The patient also had increased 4 lb weight in Apr 2021 since discharge from the hospital. Action taken with PO Orenitram dose due to the event of COVID-19 pneumonia was updated to dose decreased and for the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia, diarrhoea and limb discomfort was not reported. Action taken with nifedipine, and Medrol dose for the events of COVID-19 pneumonia, acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia diarrhoea and limb discomfort was not reported. At the time of reporting, the outcome of the events of 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 of rash and limb discomfort was recovering. The outcome of the events of pyrexia and diarrhoea was recovered on an unreported date in 2021. The reporter did not provide causality for the events of acute respiratory failure, pulmonary arterial hypertension, influenza, fluid overload, mitral valve incompetence, steroid diabetes, oedema peripheral, weight fluctuation, rash, pyrexia, diarrhoea, and limb discomfort. 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. Pfizer is a marketing authorization holder of [Nifedipine] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Nifedipine] has submitted the same report to the regulatory authorities. Information on the batch/Lot number has been requested.; Sender's Comments: Based on the temporal association and the known safety profile, a possible contributory role of BNT162B2 to the development of drug ineffective, COVID-19, pneumonia, rash, pyrexia and diarrhoea cannot be excluded. Acute hypoxemic respiratory failure was secondary to COVID-19, therefore was also considered as related to BNT162B2. The other events were considered as due to underlying or intercurrent conditions and unrelated to BNT162B2. Steroid diabetes was considered as related to methylprednisolone and other events were unrelated to methylprednisolone. Oedema peripheral and limb discomfort were considered as related to nifedipine and other events were unrelated to nifedipine. 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.