Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Retching, Somnolence
Clinical narrative: Gagging; Feels tired and sleepy all the time; Feels tired and sleepy all the time; Arm was really sore; Some choking; Anxiety; Cough during treatment; This is a solicited report (MARKETING PROGRAM NAME NOT AVAILABLE) based on the information received by Pfizer pharmacy. A contactable 75-year-old female consumer (patient)received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation; and treprostinil sodium, via inhalation from 12Feb2021 (Batch/Lot number was not reported) to an unspecified date and at 18-54 ug, 4x/day, via inhalation from an unspecified date (Batch/Lot number was not reported), at 36 ug, 4x/day for pulmonary arterial hypertension. Medical history included ongoing anxiety. The patient's concomitant medications were not reported. In Feb2021, the patient experienced event of cough during treatment. In 2021, the patient experienced event of gagging (retching). On 04Mar2021, the patient experienced event of anxiety; related it to going to the physician appointment. An additional dosage regimen of 36 ug (6 breaths), qid via IH route was added to Tyvaso. The patient reported that coughing (previously reported as cough) and gagging had improved after the treatment. The patient's current IH Tyvaso dose was 6 breaths four times a day. On 04 Mar 2021, 2 weeks 6 days after initiating IH Tyvaso, the patient had anxiety and related it to going to the physician appointment. The patient had reported ongoing anxiety since childhood. In 2021, the patient experienced the event of some choking. In 2021, the patient experienced the events of feels tired and sleepy all the time and arm was really sore (pain in extremity). The patient felt tired and sleepy all the time. Her arm was really sore and she was tired and sleepy. The outcome of the event cough and gagging was recovering while the outcome of the rest of the events was unknown. The action taken in response to treprostinil sodium for the events was unknown. An unspecified treatment was given to the patient for the event cough and gagging. The reporter assessed the causal relationship between the IH Tyvaso and the event of cough as possible. The reporter did not provide causality for the events of retching, choking, anxiety, fatigue, somnolence, and pain in extremity.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of choking,cough,gagging,and other events cannot be excluded but also contributory effect from other suspect drug TREPOSTINIL SODIUM. consider also possible contributory effects from patient's medical history and concomitant medications. 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.