Sex: M
Vaccine: COVID19, UNK
Symptoms: Constipation, Muscular weakness, Neuropathy peripheral, Oedema peripheral, Spinal claudication
Clinical narrative: Evidence of neuropathic involvement with chronic constipation; Chronic significant constipation; Reports he has gained a few pounds; Legs feel weak after extensive walking or standing; Neurogenic claudication; Very mild pedal edema; This is a spontaneous report from a Pfizer sponsored program from a contactable physician  A 85-years-old male patient received received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and tafamidis (TAFAMIDIS), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 61 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced evidence of neuropathic involvement with chronic constipation on an unspecified date with outcome of unknown, chronic significant constipation on an unspecified date with outcome of unknown, reports he has gained a few pounds (weight increased) on an unspecified date with outcome of unknown, legs feel weak after extensive walking or standing (muscular weakness)on an unspecified date with outcome of unknown, neurogenic claudication (spinal claudication) on an unspecified date with outcome of unknown, very mild pedal edema (oedema peripheral) on an unspecified date with outcome of unknown. The action taken for tafamidis was unknown.  Limited PO fluid intake Is active at the church. A lot of walking, no formal exercise. Therapeutic measures were taken as a result of chronic significant constipation (constipation) started some samples of Trulance from Gl.  Pfizer is a marketing authorization holder of Tafamidis in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Tafamidis has submitted the same report to the regulatory authorities.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, and a plausible temporal association, the causal association between the event neuropathy and the suspect drugs BNT162B2 and tafamidis cannot be totally excluded. The information available in this report is limited and does not allow  a medically meaningful assessment of the case.  In particular, the following relevant information is not available: suspect drugs start date, event onset date, relevant medical history, and concomitant medications.  Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.