Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Therapy non-responder
Clinical narrative: Brain tumor; brain cancer; brain lymphoma; No changes in symptoms or breathing overall, however their physical therapy exertion causes pt shortness of breath; No changes in symptoms or breathing overall, however their physical therapy exertion causes pt shortness of breath; Fatigued; Intermittent diarrhea; This is a solicited report received from a Consumer or other non HCP. Other Case identifier(s): UNT-2023-026131.  Case Description: This case is a solicited report received on 07Sep2023, from a consumer's spouse from a patient support program via (Pharmacy name withheld) pharmacy. This 75-year-old, female patient began therapy with Remodulin (Treprostinil sodium, concentration 5.0 mg/ml) delivered via Remunity (pharmacy filled) pump, on an unreported date in Nov2022 for pulmonary arterial hypertension (PAH). The current dose was reported as 0.02033 ug/kg, continuous via subcutaneous (SQ) route. On 06Sep2023, the patient had been admitted due to a brain tumor (brain neoplasm, hospitalized and medically significant). It was unknown if her physician (MD) was aware. Relevant medical history included PAH. Action taken with SQ Remodulin was dose not changed due to the event of brain neoplasm. At the time of reporting, the outcome of brain neoplasm was unknown. The reporter did not provide causality for the event of brain neoplasm.  Follow up information was received as a solicited report on 14Sep2023 from a consumer's spouse from a patient support program via (Pharmacy name withheld) pharmacy. Event of brain neoplasm was updated to brain neoplasm malignant. On 06Sep2023, the patient was hospitalized for chemotherapy due to diagnosis of brain cancer. While hospitalization, the patient had an echo and their pressure looked like it was holding in the 60's, not worsening. Moreover, the patient's cardiac and other pressure issues were doing better. The patient was discharged on 14Sep2023. It was further reported that chemo cycles were going to be every other week for 5 to 7 cycles and the patient would be hospitalized for each chemo treatment. Action taken with SQ Remodulin was dose not changed due to the event of brain neoplasm malignant. At the time of reporting, the outcome of brain neoplasm malignant was unknown. The reporter did not provide causality for the event of brain neoplasm malignant.  Follow-up information was received as solicited information on 05Oct2023 from a consumer's spouse from a patient support program via (Pharmacy name withheld) pharmacy. No new medically significant information was received. However, the patient's spouse reported that the patient was currently hospitalized for chemotherapy. The length of stay was ongoing. Follow-up information was received as solicited report on 08Dec2023, from a consumer's spouse from a patient support program via (Pharmacy name withheld) pharmacy. Event of brain neoplasm malignant was updated to central nervous system lymphoma (hospitalized and medically significant). Co-suspect vaccines included Covid and flu shots (unspecified). It was reported that patient had no changes in symptoms or breathing overall however, their physical therapy exertion caused the patient shortness of breath (therapy non-responder and dyspnoea exertional). She felt fatigued (fatigue) after receiving the Covid and flu shots, and needed to use their transport chair but was feeling much better on 08Dec2023. The patient had radiation for brain lymphoma as 5 days a week for 5 weeks, in 13 sessions for the whole brain and 12 sessions targeted at lesion. She had completed 5 cycles of chemo every other week with no shrinkage of lesion. On an unreported date in 2023 (in past few weeks), the patient experienced intermittent diarrhea but was manageable with Imodium (loperamide). It was unknown if PAH physician was aware of all the events. Action taken with SQ Remodulin was dose not changed due to the events of central nervous system lymphoma, therapy non-responder, dyspnoea exertional, fatigue and diarrhoea. At the time of reporting, the outcome of fatigue was considered as resolving, central nervous system lymphoma was not resolved, whereas outcome of therapy non-responder, dyspnoea exertional and diarrhoea was unknown. The reporter did not provide causality for the events of central nervous system lymphoma, dyspnoea exertional, fatigue and diarrhoea. The reporter's causality for the event of therapy non-responder with SQ Remodulin was considered to be possibly related. The reporter's causality for the event of fatigue with Covid and flu shots (unspecified) was considered to be possibly related.   Case Comment/Senders Comment: The company has assessed the serious adverse event of central nervous system lymphoma as not related to SQ treprostinil. A long-term study conducted in rats to evaluate the carcinogenic potential of treprostinil did not demonstrate any mutagenic nor clastogenic effects of treprostinil, and this supports a negative causal relationship between the event and SQ treprostinil.  The reporter considered "fatigued" related to BNT162b2. The reporter's assessment of the causal relationship of "brain tumor; brain cancer; brain lymphoma", "no changes in symptoms or breathing overall, however their physical therapy exertion causes pt shortness of breath" and "intermittent diarrhea" with the suspect product(s) BNT162b2 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. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events fatigue, and diarrhea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. Based on the given information, the Company confirms that the events dyspnoea exertional, and therapy non-responder are unrelated to the suspected drug and most likely due to the physical therapy exercises that the patient is performing at the time of the report. Due to implausible temporal association, the event central nervous system lymphoma is assessed as unrelated to suspect drug. The patient has been vaccinated with the suspect drug once, while it is known that the process of carcinogenesis takes months to years.