Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Valsalva maneuver, Vitamin B12
Clinical narrative: patient continued to experience burning and itching at the injection site; patient continued to experience burning and itching at the injection site; new-onset postural orthostatic tachycardia syndrome after COVID-19 vaccination; This is a literature report for the following literature source(s).  A 46-year-old female patient received BNT162b2 (BNT162B2), in Sep2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Raynauds Phenomenon" (unspecified if ongoing); "COVID-19", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant) with onset Sep2021, 7 days after the suspect product(s) administration, outcome "recovering", described as "new-onset postural orthostatic tachycardia syndrome after COVID-19 vaccination"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "patient continued to experience burning and itching at the injection site".   The patient underwent the following laboratory tests and procedures: Aspartate aminotransferase: (2021) 112 IU/l, notes: On day 14 post-vaccination, elevated; Blood pressure measurement: (2021) 113/83 mmHg, notes: 10 min; (2021) 113/77 mmHg, notes: 13 min; (2021) 111/82 mmHg, notes: 15 min; (2021) 114/83 mmHg, notes: 19 min; (2021) 117/84 mmHg, notes: 21 min; (2021) 102/69 mmHg, notes: Supine; (2021) 115/75 mmHg, notes: 30 s; (2021) 122/85 mmHg, notes: 1 min; (2021) 106/77 mmHg, notes: 3 min; (2021) 101/76 mmHg, notes: 5.5 min; (2021) 114/80 mmHg, notes: 7 min; (2021) 113/78 mmHg, notes: 26 min; (2021) 102/68 mmHg, notes: 30 s, post tilt; (2021) 99/65 mmHg, notes: 1 min, post tilt; (2021) 109/72 mmHg, notes: 3 min, post tilt; (2021) 108/74 mmHg, notes: 5 min, post tilt; (2021) 128/87 mmHg; Blood thyroid stimulating hormone: (2021) normal limits, notes: On day 14 post-vaccination; Body temperature: (2021) changes throughout her right arm, notes: On day 7 post-vaccination, the patient continued to experience; Carbon dioxide: (2021) 29 mmHg, notes: On day 14 post-vaccination; (2021) 19 mmHg, notes: while the patient was in supine position and further decreased by 34% down to 19 mmHg upon head-up tilt; (2021) 23 mmHg, notes: 10 MIN; (2021) 24 mmHg, notes: 13 min; (2021) 26 mmHg, notes: 15 min; (2021) 28 mmHg, notes: 19 min; (2021) 24 mmHg, notes: 21 min; (2021) 29 mmHg, notes: Supine; (2021) 28 mmHg, notes: 30 S; (2021) 29 mmHg, notes: 1 min; (2021) 19 mmHg, notes: 3 min; (2021) 21 mmHg, notes: 5.5 min; (2021) 22 mmHg, notes: 7 min; (2021) 25 mmHg, notes: 26 min; (2021) 25 mmHg, notes: 30 s, post tilt; (2021) 24 mmHg, notes: 1 min, post tilt; (2021) 23 mmHg, notes: 3 min, post tilt; (2021) 24 mmHg, notes: 5 min, post tilt; C-reactive protein: (2021) normal limits, notes: On day 14 post-vaccination; Electrocardiogram: (2021) performed, which demonstrated sinus tachycardia, notes: performed, which with a ventricular rate of 121 bpm, On day 14 post-vaccination; Full blood count: (2021) normal limits, notes: On day 14 post-vaccination; Heart rate: (2021) 127, notes: 7 min Units: Bpm; (2021) 127, notes: 10 min Units: Bpm; (2021) 126, notes: 13 min Units: Bpm; (2021) 129, notes: 15 min Units: Bpm; (2021) 129, notes: 19 min Units: Bpm; (2021) 170, notes: Units: Bpm; (2021) 93, notes: Supine Units: Bpm; (2021) 117, notes: 30 s Units: Bpm; (2021) 124, notes: 1 min Units: Bpm; (2021) 123, notes: 3 min Units: Bpm; (2021) 121, notes: 5.5 min Units: Bpm; (2021) 128, notes: 21 min Units: Bpm; (2021) 140, notes: 26 min Units: Bpm; (2021) 107, notes: 30 s, post tilt Units: Bpm; (2021) 120, notes: 1 min, post tilt Units: Bpm; (2021) 105, notes: 3 min, post tilt Units: Bpm; (2021) 88, notes: 5 min, post tilt Units: Bpm; (2021) 107, notes: BPM; (2021) up to 120 beats per, notes: up to 120 beats per minute; (2021) maximum heart rates of 170 bpm, notes: maximum heart rates of 170 bpm; (Sep2021) 9 months after she fully recovered; allergic etiology: (2021) persistent palpitations were not consistent with, notes: On day 14 post-vaccination; (2021) which included cardiovagal response to deep breath, notes: ing and Valsalva maneuver assessment during tilt-table testing  On day 14 post-vaccination; (2021) maneuver reproduced the same symptoms the patient, notes: had reported at home and the cutaneous changes consistent with Raynauds Phenomenon, which were witnessed by the autonomic laboratory clinicians; (2021) Tachycardia in response to standing and ordered a, notes: cardiac monitor, which demonstrated episodes of sinus tachycardia with maximum heart rates of 170 bpm. On day 14 post-vaccination; (2021) normal limits, notes: On day 14 post-vaccination; (2021) normal limits, notes: On day 14 post-vaccination; Deep Breathing (normal high range 10.0): (2021) 20.4, notes: HR Range (bpm), 46%; laboratory clinicians: (2021) maneuver reproduced the same symptoms the patient, notes: had reported at home and the cutaneous changes consistent with Raynauds Phenomenon, which were witnessed by the autonomic laboratory clinicians; Neurological examination: (2021) results demonstrated normal electromyography, notes: On day 14 post-vaccination; Oxygen saturation: (2021) 100 %; (2021) 100 %; Polymerase chain reaction: (Dec2020) Positive, notes: COVID-19; Red blood cell sedimentation rate: (2021) normal limits, notes: On day 14 post-vaccination; Respiration abnormal: (2021) 12, notes: Unit: breaths/min 10 min; (2021) 12, notes: Unit: breaths/min 13 min; (2021) 13, notes: Unit: breaths/min 15 min; (2021) 10, notes: Unit: breaths/min 19 min; (2021) 13, notes: Unit: breaths/min 21 min; (2021) 13, notes: Unit: breaths/min Supine; (2021) 12, notes: Unit: breaths/min 30 s; (2021) 11, notes: Unit: breaths/min 1 min; (2021) 15, notes: Unit: breaths/min 3 min; (2021) 12, notes: Unit: breaths/min 5.5 min; (2021) 12, notes: Unit: breaths/min 7 min; (2021) 13, notes: Unit: breaths/min 26 min; (2021) 13, notes: Unit: breaths/min 30 s, post tilt; (2021) 13, notes: Unit: breaths/min 1 min, post tilt; (2021) 12, notes: Unit: breaths/min 3 min, post tilt; (2021) 11, notes: Unit: breaths/min 5 min, post tilt; Thyroxine free: (2021) normal limits, notes: On day 14 post-vaccination; Tri-iodothyronine: (2021) normal limits, notes: On day 14 post-vaccination; Ultrasound scan: (2021) of her right arm showed normal arterial flow and n, notes: o evidence of deep venous thrombosis; Valsalva maneuver (normal high range 1.51): (2021) 1.69, notes: Valsalva Ratio, 19; Vitamin B12: (2021) normal limits, notes: On day 14 post-vaccination. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, vaccination site pain, vaccination site pruritus.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   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.