Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperventilation, Loss of consciousness, Pain in extremity, Peripheral swelling
Clinical narrative: my heart started fluttering all over the place; passing out; fatigue; arm pain and soreness; both arms were swollen and blotchy; both arms were swollen and blotchy; shivering; dizzy; my ears started ringing; I couldn't catch my breath and started hyperventilating; I couldn't catch my breath and started hyperventilating; Headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP) via agency. The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Dec2021 13:15 (Lot number: 30155BA) at the age of 20 years as dose 2, single for covid-19 immunisation in Doctor's office/urgent care. The patient was not pregnant when administration. Relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: GARDASIL, dose 2, single, administration date 26Nov2021. List of any other medications the patient received within 2 weeks of vaccination: N/A. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No.: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM, Route of Administration: Intramuscular), administration date: 19Nov2021, when the patient was 20 years old, for Covid-19 Immunization; Gardasil (Dose number: 1). Since the vaccination, the patient has not been tested for COVID-19. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 11Dec2021 01:15, outcome "recovering", described as "my heart started fluttering all over the place"; LOSS OF CONSCIOUSNESS (medically significant) with onset 11Dec2021 01:15, outcome "recovering", described as "passing out"; FATIGUE (non-serious) with onset 11Dec2021 01:15, outcome "recovering", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset 11Dec2021 01:15, outcome "recovering", described as "arm pain and soreness"; RASH MACULAR (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 11Dec2021 01:15, outcome "recovered" (11Dec2021) and all described as "both arms were swollen and blotchy"; CHILLS (non-serious) with onset 11Dec2021 01:15, outcome "recovering", described as "shivering"; DIZZINESS (non-serious) with onset 11Dec2021 01:15, outcome "recovering", described as "dizzy"; TINNITUS (non-serious) with onset 11Dec2021 01:15, outcome "recovered" (11Dec2021), described as "my ears started ringing"; HYPERVENTILATION (non-serious), DYSPNOEA (non-serious) all with onset 11Dec2021 01:15, outcome "recovering" and all described as "I couldn't catch my breath and started hyperventilating"; HEADACHE (non-serious) with onset 11Dec2021 01:15, outcome "recovering", described as "Headache". It was unknown if therapeutic measures were taken as a result of cardiac flutter, loss of consciousness, fatigue, pain in extremity, rash macular, peripheral swelling, chills, dizziness, tinnitus, hyperventilation, dyspnoea, headache. The events didn't result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The events were reported as non-serious. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.   Clinical course: It started off normal with. Then the patient started noticing that about 1 am then after a few minutes she started really bad. While that was happening, she got really and started, but she laid down and put my feet up before she fell. She was still shivering the whole time and had to be covered up by 4 blankets, a heating pad, and two warm rice packs to finally stop. The shivering subsided but came back around 4 am. While she was laying on the ground and then. Eventually her ears stopped but she had a after that. Once she finally got to a point to get to her bed and this was when she added the heating pad to warm up. After 20ish minutes of being in bed her arms went back to normal and the blotchiness went away. The patient did call the doctor and they recommended an Emergency Room visit but she did not go.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case provided, the causal association between the events Cardiac flutter, Loss of consciousness and the suspect drug BNT162B2 cannot be excluded considering drug-event temporal relationship. 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.