Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lethargy, Nausea, Pain in extremity
Clinical narrative: Vomited; arm is still significantly more swollen; No appetite; rash appeared on both the upper arm elbow through shoulder) and face; rash appeared on both the upper arm elbow through shoulder) and face; tired; pain in right arm; lethargy; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 11:30 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Had COVID in August 2021", start date: Aug2021 (unspecified if ongoing). Concomitant medication(s) included: ESTARYLLA; LINZESS; VENTOLIN ACCUHALER. The following information was reported: RASH (non-serious) with onset 29Nov2021 16:00, outcome "recovered" (30Nov2021), RASH (non-serious) with onset 29Nov2021 16:00, outcome "not recovered" and all described as "rash appeared on both the upper arm elbow through shoulder) and face"; FATIGUE (non-serious) with onset 29Nov2021 16:00, outcome "not recovered", described as "tired"; PAIN IN EXTREMITY (non-serious) with onset 29Nov2021 16:00, outcome "not recovered", described as "pain in right arm"; LETHARGY (non-serious) with onset 29Nov2021 16:00, outcome "not recovered", described as "lethargy"; NAUSEA (non-serious) with onset 29Nov2021 16:00, outcome "not recovered", described as "Nausea"; VOMITING (non-serious) with onset 29Nov2021 19:30, outcome "not recovered", described as "Vomited"; PERIPHERAL SWELLING (non-serious) with onset 29Nov2021 16:00, outcome "not recovered", described as "arm is still significantly more swollen"; DECREASED APPETITE (non-serious) with onset 29Nov2021 16:00, outcome "not recovered", described as "No appetite". Therapeutic measures were taken as a result of rash, rash, fatigue, pain in extremity, lethargy, nausea, vomiting, peripheral swelling, decreased appetite. Additional information: Patient received no other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. Consulting w/dr; will go in if it gets worse in case of treatment received for the adverse event. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was did not have known allergies. Device Date: 30Nov2021. For treatment, Consulting w/dr; will go in if it gets worse. Clinical course: Approx 4-5 hours after shot, rash appeared on both the upper arm (elbow through shoulder) and face. Very tired. Tried to work through the tiredness and attended a sports practice. Came home in tears from pain in right arm (shot given in right arm). Was not able to undress self due to severe pain and lethargy. Nausea started with the rash and tired feelings around the 4-5 hour mark after shot. Vomited around 8 hours after shot was administered. Nausea continued through night into morning. Rash on arm was gone by morning, but arm is still significantly more swollen than the other arm and too painful to move. Too tired to get up and has been sleeping for close to 14 hours. No appetite. Pediatrician suggested Benadryl which has helped with the rash on the face. Forcing fluids and will continue with Benadryl every 4-6 hours for the day.  The lot number for bnt162b2 was not provided and will be requested during follow up.