Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Limb discomfort, Pain in extremity, Paraesthesia, Temperature intolerance
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose 3 (booster), single (Lot number: 33036BD), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Thalassemia Trait" (unspecified if ongoing), notes: Other medical history: Thalassemia Trait; "Mitral Valve Prolapse" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EL3247, vaccine location: Left arm), administration date: 15Jan2021, for COVID-19 Immunization; BNT162b2 (Dose 2, single , Lot number: EM9810, vaccine location: Left arm), administration date: 07Feb2021, for COVID-19 Immunization, reaction(s): "palpitations", "severe chest pain". The following information was reported: PARAESTHESIA (disability) with onset 24Feb2022, outcome "not recovered", described as "Developed tingling"; LIMB DISCOMFORT (disability) with onset 24Feb2022, outcome "not recovered", described as "Feelings that there were shards of glass being thrown into my lower extremities"; FEELING HOT (disability) with onset 24Feb2022, outcome "not recovered", described as "Hot feeling"; PAIN IN EXTREMITY (disability) with onset 24Feb2022, outcome "not recovered", described as "most severe severe pain in my feet"; TEMPERATURE INTOLERANCE (disability) with onset 24Feb2022, outcome "not recovered", described as "sensations of heat". The events "developed tingling", "sensations of heat", "feelings that there were shards of glass being thrown into my lower extremities", "most severe severe pain in my feet" and "hot feeling" required emergency room visit. Therapeutic measures were taken as a result of paraesthesia, temperature intolerance, limb discomfort, pain in extremity, feeling hot. Clinical course: Developed tingling, hot feeling, and sensations of heat as well as feelings that there were shards of glass being thrown into my lower extremities within a few days of receiving the booster. Also had the most severe pain in my feet and legs and had difficulty walking (felt like patient was walking on my bones and there was no padding/flesh on the sole of my feet). Went to emergency room twice. Now being followed by podiatrist and neurologist. Patient treatment received as Toradol IV. Oxycodone PO. Gabapentin. Patient not had Covid-19 prior vaccination and not tested post vaccination. No known allergies. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.