Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Nausea, Paraesthesia, Pharyngeal swelling, Swollen tongue
Clinical narrative: face numb and droopy; face still numb and tingly; face still numb and tingly; mouth/tongue still swollen; mouth/tongue still swollen; lymph nodes swelled; dizziness/lightheaded; nausea; heavy metal taste in mouth; throat swelled; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Dec2021 09:00 (Lot number: FE3594, expiration date unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "migraine" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Known allergies: other immunizations. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fg3527, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 24Nov2021, for Covid-19 immunization, reaction(s): "lymph nodes swelled immediately", "Nausea", "Dizziness/lightheaded", "heavy metal taste in mouth". The following information was reported: FACIAL PARALYSIS (medically significant), outcome "not recovered", described as "face numb and droopy"; HYPOAESTHESIA (medically significant), PARAESTHESIA (medically significant), outcome "not recovered" and all described as "face still numb and tingly"; MOUTH SWELLING (non-serious), SWOLLEN TONGUE (non-serious), outcome "not recovered" and all described as "mouth/tongue still swollen"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "lymph nodes swelled"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness/lightheaded"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DYSGEUSIA (non-serious), outcome "not recovered", described as "heavy metal taste in mouth"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "throat swelled". Clinical course: First dose her lymph nodes swelled immediately, dizziness, lightheaded, heavy metal taste in mouth, nausea. Second dose, same symptoms but worse, then tongue swelled, throat swelled, face numb and droopy, lymph nodes swelled more than last time, metal taste now worse. After 1 month, still can't taste food because of metal taste, lymph nodes still swollen, face still numb and tingly, mouth/tongue still swollen. The events were evaluated at the emergency room visit. Therapeutic measures were taken as a result of all events and treatment included benadryl, prednisone, pepcid. There was no other vaccine in four weeks or other medications in two weeks. The patient had no covid prior vaccination or COVID tested post vaccination.; Sender's Comments: Based on the temporal association, a causal relationship between the events face numb and droopy and face still numb and tingly, and bnt162b2 (COMIRNATY) cannot be completely excluded. 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.