Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash erythematous, Swollen tongue, Throat tightness, Vaccination site pain
Clinical narrative: Neuropathy type sensation in feet, lower legs, hands; difficulty breathing; tongue felt tingly and swollen; raised red itchy rash on neck, chest and abdomen; swollen lymph glands in throat; diarrhea; sore throat; site soreness; achy joints; headache; nausea; fatigue; Racing heartbeat; throat felt lujeir was closing; tongue felt tingly and swollen; This is a spontaneous report from a contactable healthcare professional (the patient). A 66-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6205), via an unknown route of administration in the left arm on 06Mar2021 at 16:30 (at the age of 66-years-old) as a single dose for Covid-19 immunization. Medical history was included celiac sprue, Crohns, chronic pancreatitis, psoriasis, osteoporosis, and ulcerative colitis, all from an unknown date and unknown if ongoing. The patient was allergic to penicillin and codeine. The patient previously received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269) on 13Feb2021 at 11:30 in the left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported however it was reported the patient had other medications in two weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 16:30, within 5 minutes of injection, the patient experienced Racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands. The patient also experienced the typical side effects of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat, and raised red itchy rash on neck, chest and abdomen. Treatment of Benadryl was given for the events as recommended by paramedic which was still being taken on day 4. The clinical outcome of the events racing heartbeat, difficulty breathing, tongue felt tingly and swollen, throat felt lujeir was closing, and neuropathy type sensation in feet, lower legs, hands was recovered on 06Mar2021 (reported as 'last about 10 minutes'); outcome of site soreness, achy joints, headache, fatigue, nausea, sore throat, diarrhea, swollen lymph glands in throat and raised red itchy rash on neck, chest and abdomen was not recovered. It was reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) 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.