Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Off label use, Vaccination complication
Clinical narrative: Chronic obstructive pulmonary disease exacerbation; hypertension; vaccination complication; really sick; nausea; headache; The patient had decreased breaths from 12 to 10 breaths; This is a solicited report received from pharmacy. A contactable other healthcare professional and a consumer (patient) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as a single dose for COVID-19 immunization; treprostinil sodium (TYVASO, concentration of 0.6 mg/ml), resp inhalation (reported as via inhalation (IH) route) from 23Sep2020 (batch/lot number: 2101929; expiration date: 31Jan2022) to an unspecified date, delivered by Tyvaso inhalation device (TD-300/A) at 18-54 ug, QID (3-9 breaths), then via an unspecified route of administration from an unspecified date (batch/lot number was not reported) to an unspecified date, at 72 ug to 60 ug (12 to 10 breaths) for secondary pulmonary arterial hypertension. Medical history included ongoing secondary pulmonary arterial hypertension and ongoing chronic obstructive pulmonary disease. Concomitant medication included tadalafil taken for an unspecified indication, start and stop date were not reported. On 25Mar2021, the patient experienced events of chronic obstructive pulmonary disease exacerbation (chronic obstructive pulmonary disease, hospitalized), hypertension (hypertension, hospitalized) and reaction to COVID vaccine (vaccination complication, hospitalized). On an unreported date, the patient experienced events of really sick (illness), nausea (nausea) and headache (headache). On an unreported date, the patient had decreased breaths from 12 to 10 breaths (off label use). It was also reported that the patient had decreased breaths from 72 ug to 60 ug (12 to 10 breaths). The patient was really sick, nausea and headache. On 25Mar2021, 6 months and 3 days after initiating IH Tyvaso, the patient was hospitalized for reaction to coronavirus disease (COVID) vaccine, chronic obstructive pulmonary disease exacerbation, and hypertension. The patient was discharged from the hospital on 28Mar2021. The action taken in response to the events chronic obstructive pulmonary disease, hypertension and vaccination complication for treprostinil sodium was not reported, and dose was decreased due to the events illness, nausea and headache. At the time of reporting, the outcome of chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, nausea and headache was unknown. The reporter did not provide causality for the events of chronic obstructive pulmonary disease, hypertension, and vaccination complication. The reporter's causality for the events illness, nausea and headache with IH treprostinil sodium was considered to be possibly related.   Case Comment/Sender's Comment: The company has assessed the serious adverse event of chronic obstructive pulmonary disease, hypertension and vaccination complication as not related to IH treprostinil and TD-300/A device. Chronic obstructive pulmonary disease and hypertension were likely due to exacerbation of underlying COPD and Hypertension respectively. Vaccination complication was due to COVID vaccine.   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is based on the company causality assessment.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event chronic obstructive pulmonary disease, hypertension, vaccination complication, illness, headache, nausea and the suspect drug BNT162B2 , TYVASO 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.