Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Haematology test, Inappropriate schedule of product administration, Nausea, Oxygen saturation
Clinical narrative: decreased level of consciousness; Bradycardia; Respiratory distress; Abdominal pain; Penile throbbing; getting winded just from walking around at work/Felt like I was unable to get a proper full breath of air, almost like I couldnt stretch my lungs all the way.SpO2 was 95-97%.; getting winded just from walking around at work/Felt like I was unable to get a proper full breath of air, almost like I couldnt stretch my lungs all the way.SpO2 was 95-97%/Difficulty breathing; light headed; Throbbing pain in my left arm, chest, inner left thigh/leg; Throbbing pain in my left arm, chest, inner left thigh/leg; intense pulsating pain in my left testicle; Nausea; cold sweat; pale face; almost fainted; 17Aug2021 dose number 2/25Mar2021 dose number 1 on 17Aug2021 07:45; This is a spontaneous report from a contactable other hcp. A 25-year-old male patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 17Aug2021 07:45 (Batch/Lot Number: EW0175) as DOSE 2, SINGLE for covid-19 immunization. Medical history included covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes). There were no concomitant medications.  The patient experienced decreased level of consciousness on an unspecified date, bradycardia on an unspecified date, respiratory distress on an unspecified date, throbbing pain in my left arm, chest, inner left thigh/leg on 25Aug2021 02:30, intense pulsating pain in my left testicle on 25Aug2021 02:30, nausea on 25Aug2021 02:30, cold sweat on 25Aug2021 02:30, pale face on 25Aug2021 02:30, almost fainted on 25Aug2021 02:30, getting winded just from walking around at work/felt like I was unable to get a proper full breath of air, almost like i couldnt stretch my lungs all the way.spo2 was 95-97%/difficulty breathing on 30Aug2021, 17Aug2021 dose number 2/25Mar2021 dose number 1 on 17Aug2021 07:45, light headed on 30Aug2021, abdominal pain on an unspecified date, Throbbing/Penile throbbing on an unspecified date. Patient reported "Woke up to agonizing Throbbing pain in my left arm, chest, inner left thigh/leg and intense pulsating pain in my left testicle. Nausea, cold sweat, pale face and almost fainted. On 30Aug2021, was getting winded just from walking around at work. Felt like I was unable to get a proper full breath of air, almost like I couldnt stretch my lungs all the way.  SpO2 was 95-97%". Onset 8 days after vaccine chest pain, left arm, left leg, and groin. Lasted about 2 hours. 14 days after injection difficulty breathing, winded and light headed/faint. Lasted 3 days. Arrived in the (ED) emergency department around 4 AM. (EKG) Electrocardiogram taken with bloodwork and urine sample. EKG showed bradycardia. D-dimer test under 6. Difficulty breathing (without wheeze or stridor): Yes. The events decreased level of consciousness, bradycardia and respiratory distress was reported as serious-medically significant. The patient underwent lab tests and procedures which included Blood work (blood test): unknown on an unspecified date, EKG (electrocardiogram): bradycardia on an unspecified date, Ddimer test (fibrin d dimer): under 6 on an unspecified date, Hematology (haematology test): unknown on 25Aug2021, SpO2 (oxygen saturation): 92 % on an unspecified date and 95-97% % on 30Aug2021, Antigene test/ Rapid covid19 test (polymerase chain reaction): negative on 30Aug2021 (Nasal Swab) and Urine sample (urine analysis): unknown on an unspecified date. The outcome of the events decreased level of consciousness, Respiratory distress, intense pulsating pain in my left testicle, Nausea, cold sweat, pale face, almost fainted, Abdominal pain and Throbbing/Penile throbbing was recovered on unspecified date. Throbbing pain in my left arm, chest, inner left thigh/leg was recovered on 25Aug2021. Getting winded just from walking around at work/Felt like I was unable to get a proper full breath of air, almost like I couldnt stretch my lungs all the way.SpO2 was 95-97% and light headed was recovered on 02Sep2021. Outcome of all the other events was unknown.  No follow-up attempts are needed. No further information expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Depressed level of consciousness, Bradycardia, and Respiratory distress and BNT162B2.  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.