Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart sounds, Human chorionic gonadotropin, International normalised ratio, Magnetic resonance imaging
Clinical narrative: Potential stress reaction vs atypical migraine vs other neuropathy; Potential stress reaction vs atypical migraine vs other neuropathy;   This is a non-interventional study report (Post Authorization Safety Study) received from a contactable reporter(s) (Other HCP).  A 46-year-old female patient received BNT162b2 (BNT162B2), on 28Dec2020 at 10:00 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation (reported as COVID-19 prophylaxis). The patient's relevant medical history included: "varicella", start date: 1982, stop date: 1982; "Atypical migraines" (unspecified if ongoing), notes: Fer patient: manifest in abnormal neurologic symptoms, neer headache or pain; had them when she was pregnant; her daughter and mother had migraines; "Vitamin D deficiency" (unspecified if ongoing); "major depression (single episode), in partial remission" (unspecified if ongoing); "gravida 6" (unspecified if ongoing), notes: para 6, term, 3 living, 3. Concomitant medication(s) included: WELLBUTRIN XL oral (ongoing); VITAMIN D3 oral (ongoing); MIRENA (ongoing); CHOLECALCIFEROL. Past drug history included: Amoxicillin, reaction(s): "rash". The following information was reported: STRESS (hospitalization), NEUROPATHY PERIPHERAL (hospitalization) all with onset 28Dec2020, all described as "Potential stress reaction vs atypical migraine vs other neuropathy". Clinical course: The participant received her first dose of COVID-19 vaccine on 28Dec2020. On 28Dec2020, at approximately 10:53, the participant presented to the emergency department (ED) with sudden onset of right sided shoulder numbness that expanded to the right side of her face and lower extremity. The participant reported that at 10:00 that day, she received the COVID vaccine in her right deltoid. Fifteen minutes after she received the vaccine, the participant developed right arm numbness, then facial and leg numbness. She was brought to the ED and noted to have left-sided symptoms. On 28Dec2020, at 10:53, code stroke was activated according to protocol. The participant was placed in the CEU for additional testing and neurology recommendations. The participant denied visual changes, slurred speech, and difficulty with speech, word finding. She denied difficulty swallowing. She reported right and left sided numbness but denied tingling. She stated, "it feels heavy." She denied weakness, difficulty walking or performing daily tasks such as going to the bathroom and eating. She also denied nausea, vomiting, diarrhea and abdominal pain; she reported good oral intake. The participant reported a history of atypical migraines that manifested in abnormal neurologic symptoms (not described) but never a headache or pain. The participant reported she developed a typical migraines when pregnant with her son only. Physical examination revealed that the participant was in no acute distress. She was alert and oriented to person, place and time. Glasgow Coma Scale (GCS) included: eye sub score 4, verbal sub score 5, and motor sub score 6. Cranial nerves were intact; no deficits noted. She had symmetrical facial expressions and normal speech. The participant reported symmetrically decreased sensation to light touch. Upon palpation, the participant reported a "dense" sensation of right side, in comparison to left side. Sensory deficit was present on the V3 distribution to the right side of face (appeared more sharp); L4 sensation appeared more sharp. Her reflexes were normal. She exhibited normal strength with 5 out of 5 strength throughout all extremities. She had a normal gait without ataxia. Vital signs included temperature 36.6 degree Celsius, blood pressure 133/98 mmHg (sitting position), when repeated blood pressure was 111/75 mmHg, pulse 106 beats per minute, respirations 18 breaths per minute and oxygen saturation 99%. Her skin was warm and dry; no rashes, erythema, pallor or diaphoresis was noted. She had normal range of motion. Heart sounds were normal with normal rate and regular Rhythm. Pulmonary effort was normal with normal breath sounds. Bowel sounds were normal with no abdominal distention. Abdomen was soft and nontender. Laboratory and diagnostic tests were obtained. A neurological consultation was placed. The neurology team evaluated the participant and there was no intervention at that time. She was placed under the minor neurologic deficit protocol. Treatment included intravenous (IV) magnesium sulfate, 2 grams in 50 mL, IV calcium gluconate, 1 gram, and ibuprofen. Her electrolyte abnormalities were corrected. Overnight, she denied any change in her symptoms. On 29Dec2020, at 07:30 and 09:30, the treating physician spoke with the neurology team. The neurology team reviewed the magnetic resonance imaging (MRI) scan and indicated the participant could be discharged from the CEU without waiting for a neurology team reevaluation. The participant was made aware and it was reported that she was comfortable being discharged without neurology reevaluation. A referral was placed for outpatient neurology. The participant was instructed to follow up with her family doctor in three to five days for reevaluation of her symptoms. Diagnostic Testing Results: 28Dec2020 10:54: Electrocardiogram(EKG): Normal sinus rhythm; 11 :20: Computed tomography (CT) scan head/neck angiogram, stroke code with contrast: No acute intracranial large vessel occlusion; no hemodynamically significant stenosis in neck; 15:29: Urine (HCG) pregnancy test: Negative; 16:07: CT brain, stroke code without contrast: No acute intracranial abnormalities; 18:05: POC Coronavirus (COVID-19)- SARs-Cov-2 Rapid Test, (nasal swab): Not detected; 21 :25: Magnetic resonance imaging (MRI) brain with and without contrast: Normal no suspicious enhancement. Physician assessment: "This did not seem to be ascending or involving respiratory symptoms going against something like Guillain-Barre. No Ascending or descending symptom;" Diagnosis/clinical impression: Potential stress reaction vs atypical migraine vs other neuropathy. The patient underwent the following laboratory tests and procedures: Blood sodium (135-145): (28Dec2020) 140 mmol/L, notes: 11:39; (28Dec2020) 138 mmol/L, notes: 14:00; Blood potassium (3.5-5.0): (28Dec2020) 2.9 mmol/L, notes: 11:39; (28Dec2020) 3.6 mmol/L, notes: 14:00; Blood chloride (98-108): (28Dec2020) 119 mmol/L, notes: 11:39; (28Dec2020) 109 mmol/L, notes: 14:00; Blood glucose (70-140): (28Dec2020) 82 mg/dl, notes: 11:39; (28Dec2020) 94 mg/dl, notes: 14:00; International normalised ratio (0.9-1.1): (28Dec2020) 1.2, notes: 11:39; Prothrombin time (9.5-13.1): (28Dec2020) 13.6 seconds, notes: 11:39; Activated partial thromboplastin time (36.8-37.1): (28Dec2020) 27.6 seconds, notes: 11:39; Haemoglobin (12.0-15.5): (28Dec2020) 10.1 g/dl, notes: 11:39; Haematocrit (35-45): (28Dec2020) 30 %, notes: 11:39; Platelet count (150-450): (28Dec2020) 220 x10 9/l, notes: 11:39; Blood calcium (1.15-1.32): (28Dec2020) 0.94 mmol/L, notes: 11:39; (29Dec2020) 1.19 mmol/L, notes: 08:40; Blood magnesium (1.8-2.5): (28Dec2020) 1.5 mg/dl, notes: 11:39; (29Dec2020) 1.9 mg/dl, notes: 08:40. The action taken in response to the event with study vaccine was not applicable. The clinical outcome of the event was unknown.   The reporter considered "potential stress reaction vs atypical migraine vs other neuropathy" related to BNT162b2 but unrelated to concomitant drugs.; Sender's Comments: Based on possible temporal association the causal role of  reported events cannot be excluded for  suspect product  .Case will be reviewed further on receipt of FU information.