Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Paraesthesia oral, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hands and feet; numbness, tingling, and swelling of her hands and feet; muscle weakness; unable to walk unassisted; Vitamin D deficiency; muscle cramps in her lower extremities that progressed to her upper extremities and neck; muscle soreness in her lower extremities that progressed to her upper extremities and neck; intermittent numbness/tingling of my inner upper lip; intermittent numbness/tingling of my inner upper lip; This is a spontaneous report from a contactable other healthcare professional (HCP) reported for herself. A 39-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (Batch/Lot Number: EN16208) at the age of 39-years-old as single dose for covid-19 immunisation. Patient was not pregnant. Medical history included Hormonal Acne, gastrooesophageal reflux disease (GERD). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; esomeprazole magnesium (NEXIUM) taken for an unspecified indication, start and stop date were not reported; aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin monohydrate (KEFLEX) and experienced allergy. The patient initially had some intermittent numbness/tingling of her inner upper lip that began within the first hour of receiving the vaccine on 19Mar2021 and lasted about 24 hours. Six days following vaccination on 25Mar2021, the patient began having muscle cramps/muscle soreness in her lower extremities that progressed to her upper extremities and neck, By the eighth day on 27Mar2021, she had developed numbness, tingling, and swelling of her hands and feet. On this day, she also began having muscle weakness and was unable to walk unassisted by the end of the day. She was seen in the Emergency room (ER), admitted, and transferred to another facility. The patient hospitalized for 1 day. She underwent a Computerised tomogram (CT) scan of my head, Magnetic resonance imaging (MRI) of my brain/neck, lumbar puncture, and extensive blood work. All of her work up was unremarkable except for showing that she had a Vitamin D deficiency. Her symptoms began to improve without treatment in the hospital, and she was discharged home with the diagnosis that she had most likely had an unusual, adverse reaction to her 1st dose of the COVID 19 vaccine and was instructed not to receive my 2nd dose. Covid tested post vaccination (Nasal swab) on 28Mar2021: Negative. The outcome of the events 'numbness/tingling of my inner upper lip' was recovered on 20Mar2021 and the outcome of the other events was recovering.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Myalgia, Muscle cramps, Hypoasthesia, Parasthesia, Pheripheral swelling, Muscle weakness and Vitamin D Defiency. 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.