Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Paraesthesia oral, Throat tightness
Clinical narrative: tingly feeling to my lips; some lip swelling; tightness in my throat.; This is a spontaneous report from a contactable Other HCP.   A 35-years-old female patient started to receive BNT162B2, via an unspecified route of administration from 30Dec2020 12:00 to 30Dec2020 12:00 at SINGLE DOSE for covid-19 immunisation.   Medical history included hypersensitivity from an unknown date and unknown if ongoing, gastritis from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing.   Concomitant medication included lorazepam (ATIVAN), ivermectin (IVERMECTIN), escitalopram oxalate (LEXAPRO), esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), levocetirizine dihydrochloride (XYZAL).  The patient previously took tamiflu and experienced drug hypersensitivity.   The patient experienced tingly feeling to my lips (paraesthesia oral) (non-serious) on 30Dec2020 15:30 with outcome of recovered, some lip swelling (lip swelling) (non-serious) on 30Dec2020 15:30 with outcome of recovered, tightness in my throat. (throat tightness) (non-serious) on 30Dec2020 15:30 with outcome of recovered.   The action taken in response to the event(s) for BNT162B2 was not applicable.   Therapeutic measures were taken as a result of tingly feeling to my lips (paraesthesia oral), some lip swelling (lip swelling), tightness in my throat. (throat tightness).  This is a spontaneous report from a contactable other HCP. This 35-year-old female other HCP reported that:  Report about covid vaccine: Yes Reporter type: Patient   Age group: Adult (18-64 Years) Is pregnant: No Race: (race provided) Ethnicity: (ethnicity provided) Patient occupation: Other Health Professional  Covid vaccine details: product-COVID 19, Lot number-EL1284, Lot unknown-False, Administration date-30Dec2020, Administration time-12:00 PM, Vaccine location-Left arm, Dose number-1  Facility type vaccine: Hospital If other vaccine in four weeks: Yes Other vaccine 4weeks details: other vaccine 4weeks product -Allergy Immunotherapy injections , Other vaccine 4weeks vaccine date -07Dec2020, Other vaccine 4weeks dose number -2 , Other vaccine 4weeks vaccine location-Left and right arm. Other medications in two weeks: Nexium, xyzal, Ativan, Lexapro, Ivermectin Adverse event: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor.   Adverse event start date: 30Dec2020 Adverse event start time: 3:30PM AE resulted in: None of the above  If patient recovered: Recovered   If treatment AE: Yes   AE treatment: Benadryl for 48 hrs   If covid prior vaccination: No   If covid tested post vaccination: No  Known allergies: Tamiflu  Other medical history: Chronic allergies, gastritis, anxiety, Depression   Identification of the case safety report  Serious: No Seriousness criteria-Results in death: No Seriousness criteria-Life threatening: No Seriousness criteria-Caused/prolonged hospitalization: No Seriousness criteria-Disabling/Incapacitating: No Seriousness criteria-Congenital anomaly/birth defect: No  VAERS Primary Reporter Addl Qualification: Patient     Relevant medical history and concurrent conditions:  Structured information (Patient episode name): Chronic allergies, gastritis, anxiety, depression     Reaction(s)/Event(s): Reaction/event as reported by primary source: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I  Reaction/event in terminology (LLT) : At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of B Date of start of reaction/event: 30Dec2020 Outcome of reaction/event at the time of last observation: RECOVERED/RESOLVED  Drug(s) Information: Characterization of drug role: Suspect Batch/lot number: EL1284     Date of start of drug:30Dec2020  Anatomical location: Arm left Dose number:1  Active drug substance information: Active drug substances name: COVID 19  Drug(s) Information: Characterization of drug role: CONCOMITANT  Proprietary medicinal product name: Allergy Immunotherapy injections   Date of start of drug:07Dec2020  Dose number:2  Narrative case summary and further information:  Case narrative  Age at vaccination: 35  Pregnant at the time of vaccination?: No Start Date/Time:30Dec2020 12:00 PM Facility where the most recent COVID-19 vaccine was administered: Hospital Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Yes List of any other medications the patient received within 2 weeks of vaccination: Nexium, xyzal, Ativan, Lexapro, Ivermectin   Reported Event: At about almost 4 hrs after receiving the injection I started to experience a tingly feeling to my lips, some lip swelling and tightness in my throat. I had my epi pen on hand incase I needed it but I ended up taking 25mg of Benadryl, then 50 mg of Benadryl 5 hrs later. The following morning my lips where feeling tingly again so I took 25mg of Benadryl again and continued for the next 48 hrs at the advice of my doctor. Was treatment received for the adverse event?: Yes: Benadryl for 48 hrs Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Allergies to medications, food, or other products: Tamiflu Vaccine Facility information available. Ethnicity information is available. Race information is available. Location of injection information is available for other vaccines within 4 weeks PRIOR.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.