Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypotension, Incorrect dose administered, Loss of consciousness, Malaise
Clinical narrative: Almost passing out/ see black like she would pass out; got fourth Covid vaccine; Heart races; Often dripping sweat/Diaphoresis; Not feel well usually at night/ feeling pretty sick; Blood pressure machine cannot read the blood pressure maybe because too low; Massive diarrhea; Jaw pain; Numbness in hands and feet; Headaches; Hot flashes; Nausea; Constipated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): UNT-2022-001047.  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 4 (booster), single for covid-19 immunisation; treprostinil (TREPROSTINIL), first regimen oral (Batch/Lot number: unknown), second regimen oral (Batch/Lot number: unknown) at 10 mg 3x/day and third regimen oral (Batch/Lot number: unknown) at increased dose for pulmonary arterial hypertension; treprostinil diolamin (ORENITRAM), oral (Batch/Lot number: unknown) at 5 mg for pulmonary arterial hypertension. Relevant medical history included: "Primary pulmonary arterial hypertension" (unspecified if ongoing), notes: Relevant medical history included: primary pulmonary arterial hypertension. Concomitant medication(s) included: AMBRISENTAN; TADALAFIL. Vaccination history included: Covid-19 vaccine (Dose-1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose-2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose-3, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovering", described as "Almost passing out/ see black like she would pass out"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "got fourth Covid vaccine"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart races"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "Often dripping sweat/Diaphoresis"; MALAISE (non-serious), outcome "unknown", described as "Not feel well usually at night/ feeling pretty sick"; HYPOTENSION (non-serious), outcome "unknown", described as "Blood pressure machine cannot read the blood pressure maybe because too low"; DIARRHOEA (non-serious), outcome "recovering", described as "Massive diarrhea"; PAIN IN JAW (non-serious), outcome "not recovered", described as "Jaw pain"; HYPOAESTHESIA (non-serious), outcome "recovering", described as "Numbness in hands and feet"; HEADACHE (non-serious), outcome "not recovered", described as "Headaches"; HOT FLUSH (non-serious), outcome "unknown", described as "Hot flashes"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CONSTIPATION (non-serious), outcome "unknown", described as "Constipated". Therapeutic measures were taken as a result of pain in jaw, headache. The patient was supplied with Orenitram 5 mg, and the current dose was reported as 10 mg, oral (PO), three times daily (TID). The patient reported that she was taking Orenitram, and reported that her heart races, often dripping sweat, almost passing out due to Orenitram and did not feel well usually at night. She also reported that blood pressure machine could not read her blood pressure, might be because it was too low. On an unreported date, the patient experienced events of massive diarrhea (diarrhoea), jaw pain (pain in jaw) and numbness in hands and feet (hypoaesthesia). It was reported that when the patient tried to increase above Orenitram 10 mg three times a day, she had every side effect under the sun. From midnight to 4:30 am she would see black like she would pass out (previously reported presyncope). She had diaphoresis (previously reported hyperhidrosis) and would be drenched like she had a shower. She was much better now that she was staying at the 10 mg dose. The patient stated that the physician wanted her to go up weekly or more often, but she did better with every 2 week increases. On an unreported date in 2022, the patient experienced the events of headaches, hot flashes, nausea and constipated. It was reported that the patient had been feeling pretty sick (previously reported as malaise) this week (in the week of reporting), got fourth Covid vaccine so thought that could have increased her symptoms. The patient also reported that she continued to have jaw pain and headaches since increased PO Orenitram to 10 mg three times a day, and for which Tylenol (paracetamol) did not work. She had hot flashes and dripping sweat (previously reported as hyperhidrosis), nausea and diarrhea and the brat diet was making her constipated. Action taken with PO Orenitram dose for the events of palpitations, malaise, hypotension, headaches, hot flush, nausea and constipation was not reported. Action taken with PO Orenitram dose for the events of hyperhidrosis, presyncope, diarrhoea, pain in jaw and hypoaesthesia was dose decreased.  The reporter's causality for the events presyncope, hyperhidrosis, diarrhoea, pain in jaw, hypoaesthesia and headache with PO Orenitram was considered to be possibly related. The reporter did not provide causality for the events of palpitations, malaise, hypotension, hot flush, nausea and constipation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   All  the reported  events and the suspect drug BNT162B2 cannot be excluded. 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