Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Grunting, Hypertension, Memory impairment, Oral mucosal blistering, Oxygen saturation
Clinical narrative: Respiratory distress; sleeps a lot; out of breath/ difficulty breathing; memory (short) problem; blister mouth; high blood pressure; oxygen 83-85; Temperature-100.3/100.8 Fahreinheit; Grunting; Dry cough; This is a spontaneous report from a contactable other healthcare professional. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Sep2021 23:00 (Lot Number: FC3182) (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. Medical history included covid-19 from Jun2020 and in 30Jun2020 for 10 days in hospital with Covid. The patient's concomitant medications were not reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior event being reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Aug2021 10:44 (Lot Number: EW0176) (at the age of 79-years-old) as dose 1, single for covid-19 immunisation and experienced short term memory, brain fog, sleeping a lot, out of breath. After 2nd injection on unspecified date in 2021, patient had 100.3/100.8 Fahrenheit degrees, high blood pressure, O2 (oxygen saturation) 83-85 for 5 days and out of breath. The signs and symptoms included sleeps a lot, out of breath, memory (short) problem, blister mouth in 2021. The time course of the reaction was between approximately 5 days and now. The patient did not require medical intervention for the events. The patient was not seen in the emergency department. The patient was not admitted to an intensive care unit. The Multiorgan involvement included Respiratory (out of breath) with respiratory distress, grunting (during night the most), dry cough, difficulty breathing. There was no hoarse voice, and it was unknown if patient had recession and cyanosis. The patient provided information to the reporter regarding the reported adverse event with the use of the product and the reporter considered the Pfizer product had a causal effect to the adverse. The outcome of blood pressure high, oxygen saturation decreased, body temperature increased was recovered in 2021 and outcome of all other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of bnt162b2 cannot be excluded for the reported event Respiratory distress. 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.