Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia oral, Oral pruritus, Paraesthesia, Paraesthesia oral
Clinical narrative: Allergic Reaction; Numbness and tingling of mouth, lips and tongue; tingling of mouth, lips and tongue; Itching in throat; tingling in face; itchy mouth; throat was tight; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 10Aug2021 12:20 (Lot number: EW0179) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Milk containing products" (unspecified if ongoing); "allergies" (ongoing). Concomitant medication(s) included: ALLEGRA taken for hypersensitivity (ongoing); PROZAC; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]. Past drug history included: Vicodin, reaction(s): "Known allergy: vicodin"; Percocet, reaction(s): "Known allergies: percocet"; Tylenol, reaction(s): "Known allergies: tylenol". Vaccination history included: Pneumonia vaccine, reaction(s): "Known allergies: Pneumonia vaccine". The following information was reported: HYPERSENSITIVITY (medically significant) with onset 10Aug2021 12:40, outcome "recovered" (13Aug2021), described as "Allergic Reaction"; HYPOAESTHESIA ORAL (non-serious) with onset 10Aug2021 12:40, outcome "recovered", described as "Numbness and tingling of mouth, lips and tongue"; PARAESTHESIA ORAL (non-serious) with onset 10Aug2021 12:40, outcome "recovered", described as "tingling of mouth, lips and tongue"; THROAT IRRITATION (non-serious) with onset 10Aug2021 12:40, outcome "recovered", described as "Itching in throat"; PARAESTHESIA (non-serious) with onset 10Aug2021 12:40, outcome "recovered", described as "tingling in face"; ORAL PRURITUS (non-serious) with onset 10Aug2021 12:40, outcome "recovered", described as "itchy mouth"; THROAT TIGHTNESS (non-serious) with onset 10Aug2021 12:40, outcome "recovered", described as "throat was tight". The events "allergic reaction", "numbness and tingling of mouth, lips and tongue", "tingling of mouth, lips and tongue", "itching in throat", "tingling in face", "itchy mouth" and "throat was tight" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test unknown results, notes: Nasal Swab. Therapeutic measures were not taken as a result of hypersensitivity. Therapeutic measures were taken as a result of hypoaesthesia oral, paraesthesia oral, throat irritation with 25 mg of Benadryl x2, continued Benadryl every 4hrs for 3 days per vaccine nurse Instruction.  Clinical course: Onset 20 minutes after vaccine administered: Itching in throat for 24 hours. Numbness and tingling of mouth, lips and tongue for 3 days. Developed itchy mouth, tingling in lips, tongue and face, throat was tight. Took 25 mg of Benadryl x2, continued Benadryl every 4hrs for 3 days per vaccine nurse Instruction. Symptoms resolved 72 hrs later.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not diagnosed with covid-19 prior to vaccination and patient tested for COVID-19 post vaccination. Specific Relevant Test for Thromboembolic Events with Thrombocytopenia reported as none.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to 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.