Symptomtext
Arm rash; fever for a week; extreme fatigue that was progressive just as the brain fog; extreme fatigue that was progressive just as the brain fog; parasthesias all over body; sweats; chest pain/pressure; chest pain/pressure; shortness of breath; rattling sound in throat; difficulty swallowing; choking; neck pain; head and chest pressure; elevated blood pressure; low pulse and oxygenation; low pulse and oxygenation; spine and hip pain; spine and hip pain; left lower leg and foot swelling; This is a spontaneous report from a contactable Nurse reporting for herself A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 09Jan2021 at 16:30 via an unspecified route of administration, in Arm Right at single dose for covid-19 immunisation. Medical history included perennial allergy, hot flush and vitamin d decreased. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR), mometasone furoate (FLONASE [MOMETASONE FUROATE]), escitalopram. The patient previously took demerol and experienced drug hypersensitivity, hydrocodone and experienced vomiting and dizziness. The patient received first dose of BNT162B2 on 22Dec2020 at 11:15 pm. On 09Jan2021 at 20:00 the patient experienced Arm rash, fever for a week, extreme fatigue that was progressive just as the brain fog, parasthesias all over body, sweats, chest pain/pressure, shortness of breath, rattling sound in throat, difficulty swallowing, choking, neck pain, head and chest pressure, elevated blood pressure, low pulse and oxygenation, spine and hip pain, left lower leg and foot swelling. All the events were assessed serious as disabling. At the time of the reporting the patient had not yet recovered from the events. The information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the strong drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events 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 RAs, Ethics Committees, and Investigators, as appropriate.