Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin exfoliation, Syncope, Tachycardia, Temperature intolerance, Tenderness
Clinical narrative: having discoloration on her toes; she was having numbness and tingling; she was having numbness and tingling; her extremities, from the knee down and both her hands and feet were cold,ice cold; Tachycardia; palpitation/palpitation complications without doing anything straight away; Pulse keeps raising, elevating to 148-157/Pulse went to 209; shortness of breath and basically blasting of air; Difficulty breathing; Dizziness; Weakness; Syncope episodes; Costochondritis; chest pain; The initial case was missing the following minimum criteria: suspect product was not reported or specified. Upon receipt of follow-up information on 06Apr2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 (Batch/Lot Number: EL3246) (at the age of 36-year-old) as single dose for COVID-19 immunisation.  Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medication included topiramate (TOPAMAX) at 250 mg, daily (2 DF 100mg and 1 DF 50mg at bedtime) taken for migraine, start and stop date were not reported. The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Dec2020 (Lot Number: EK5730) for COVID-19 immunization. The patient reported that since the second vaccination experienced tachycardia, palpitation, shortness of breath and basically blasting of air, difficulty breathing, dizziness and weakness, all on 18Jan2021. She reported pulse keeps raising, elevating to 148-157, she had palpitation complications without doing anything straight away. Elevated pulse and tachycardia, that all started and that was very concerning, pulse went to 209 and that was when she got transported to the emergency room. The patient reported also syncope episodes, costochondritis and chest pain on Jan2021.  On 26Mar2021 the patient experienced having discoloration on her toes, numbness and tingling and that her extremities, from the knee down and both her hands and feet were cold, ice cold. The patient was transported to the hospital by ambulance three times due to the events (hospitalizations on 22Jan2021, 30Jan2021 and 25Mar2021). The patient underwent lab tests and procedures which included Troponin, D dimer, electrocardiogram (EKG), Chest X ray, Full blood count (CBC), exercise electrocardiogram (TMT) all resulted: normal, nuclear stress test: unknown results and pulse 148-157, 209,  all on unspecified date. The patient outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the tachycardia and other reported events  due to temporal relationship.  However, the reported events may possibly represent intercurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  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.