Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Fluid retention, Hypersomnia, Injury, Malaise, Red blood cell count
Clinical narrative: the patient experienced event of COVID-19; for a blood transfusion to get her blood counts up; water retention; Red blood cell count low; suspected; is not herself; low iron; sleeping a lot; had no appetite; had nose bleed recently from oxygen; lost her hearing/ has tubes in her ears; infected ear; was not able to do anything; knocked her down; This is a spontaneous report from a non-contactable consumer and contactable Other-HCP. A 79-year-old female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection), via an unspecified route in 2021, as a single dose for covid-19 immunization. Medical history included primary pulmonary arterial hypertension, ongoing, transfusion procedure in May2021 and ear tube insertion procedure in 2021. Concomitant medications included ambrisentan and tadalafil. Co-suspect medications included treprostinil diethanolamine (ORENITRAM) extended-release tablet, unk mg (Lot number: 2101840, Exp. Date: 28Feb2022), extended-release tablet, 1 mg (Lot number: 2101841, Exp. Date: 28Feb2022), extended-release tablet, 2.5 mg (Lot number: 2101810, Exp. Date: 31Jan2023), extended-release tablet, unk mg (Lot number: 2101646, Exp. Date: 31Jan2022), extended-release tablet, 5 mg (Lot number: 2101811, Exp. Date: 31Jan2023) and additional dosage regimen of 5.25 mg TID, oral for primary pulmonary arterial hypertension, tadalafil resulted red blood cell count decreased, fluid retention and oxygen which was drug withdrawn on an unreported date in 2021 due to the event of epistaxis. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection), via an unspecified route in 2021, as a single dose for covid-19 immunization. On 01Apr2021, the patient experienced event of COVID-19 (COVID-19, hospitalization). On an unreported date in 2021, the patient experienced event of lost her hearing, has tubes in her ears, patients one of the tubes placed in ears fell out and one got infected, infected ear (device related infection, medically significant, device dislocation, medically significant and ear infection), So, her physician gave drops for her ears. She was sleeping a lot, low iron and she was now on an iron pill. On an unreported date in 2021, the patients second COVID vaccine knocked her down, was not able to do anything and had nose bleed recently (in Jun2021) from oxygen, while she was able to stop it (oxygen) on her own (previously reported epistaxis) about a week and half ago (from the time of reporting) and had a hard time getting it to stop. On 01Jul2021, the patient almost went to the hospital in night because she was not doing well (previously reported malaise), and they thought it was because of the PO Orenitram dose increases. It was also reported that the patient had no appetite, and she was not herself. On 01Apr2021, 1 year 3 months 15 days after initiating PO Orenitram, the patient was hospitalized due to COVID-19, and was discharged from the hospital on 07Apr2021. The patient was again hospitalized from 25May2021 to 27May2021 for a blood transfusion to get her blood counts up. On 18May2021, patient experienced red blood cell count decreased and fluid retention. The reporter assessed the causal relationship between PO Orenitram and the event of malaise as possible. The reporter did not provide causality for the events of device related infection, device dislocation, ear infection, decreased appetite, and feeling abnormal. The company has assessed the serious adverse events of red blood cell count decreased, fluid retention, COVID-19, deafness, device related infection, device dislocation, and malaise as not related to Orenitram. The event red blood cell count decreased was likely related to iron deficiency anemia, which is common in the elderly, in view of the treatment with iron and blood transfusion. The event fluid retention was likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event COVID-19 was related to the current SARS-CoV-2 virus pandemic with the event malaise possibly being symptomatic of the COVID-19 infection; however, it is also noted that the patient had received co-suspect COVID-19 vaccine, therefore it is plausible COVID-19 vaccine was possibly causal for the event malaise. The event deafness was possibly related to COVID-19 infection and managed with tympanostomy tube placement, which is a rather unusual procedure for adults with deafness. However, additional confounding factors for deafness in this patient include advanced age in which deafness is common, and treatment with co-suspect medication tadalafil, which was possibly causal in view of its safety profile, and as such cannot be excluded. The events device related infection and device dislocation were related to the tympanostomy tubes dislodging, which is typical for this device, with the device related infection likely referring to infection and/or fluid collection the middle ear itself as the purpose of the tympanostomy tube itself is to aid drainage of fluid from the middle ear. The patient underwent lab test and procedure which included blood count abnormal on 25May2021, blood iron low, Red blood cell count and weight measurements 133 lbs and 134 lbs. The clinical outcome of events COVID-19, deafness, hypersomnia, blood iron decreased, malaise and epistaxis were unknown at the time of this report.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.