Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: outbreak of hives; itching; Sore arm for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: Jan2016 (unspecified if ongoing), notes: Treatment for Asthma: Reporter stated, "She takes 1 Puff of Flovent, it is a inhaler and it's a 44 mg dose, one puff a day. She is been on it for years."; "food allergies" (unspecified if ongoing), notes: she does have food allergies. Concomitant medication(s) included: FLOVENT taken for asthma. The following information was reported: URTICARIA (hospitalization) with onset 17Jan2022, outcome "recovering", described as "outbreak of hives"; PRURITUS (non-serious) with onset 18Jan2022, outcome "unknown", described as "itching"; PAIN IN EXTREMITY (non-serious) with onset 14Jan2022, outcome "unknown", described as "Sore arm for a couple of days". The patient was hospitalized for urticaria (start date: 18Jan2022). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) negative, notes: I think it was a rapid test. Therapeutic measures were taken as a result of urticaria. Clinical Information: Reporter stated her daughter had her 1st dose of the Pfizer BioNTech Covid19 vaccine last Friday 14Jan2022 after a couple of days (Monday, 17Jan2022) her daughter started having outbreak of hives in the torso of her body, they treated it with Benadryl, Hydrocortisone and it was cleared off but it came back last night 18Jan2022 her daughter was really itching again an hour later the hives wide spread and reached her back, then they took her to the hospital. Per reporter, the doctors first suspicion was it's the Omicron variant, but her daughter tested negative and the doctor suspects that the side effects come from the vaccine. Reporter stated that her daughter had no issues with other vaccines before and this event is very surprising. Reporter daughter was supposed to go back on 04Feb2022 for the 2nd dose, and reporter is looking for data or information on this adverse event and what are Pfizer's recommendations on getting the 2nd shot. She received that on Friday 14Jan2022, she has since then, she had a normal reporter guess sore arm for a couple of days and then Monday so this would be January 17th she started having like she guesses periodic breakouts and hives on different part of her body, it comes and goes. We had been treating it at home with just topical like hydrocortisone (treatment) and then Benadryl (treatment) and it seems like that was helping but then last night so this would have been Tuesday reporter think 18Jan2022, it had go in either she had, it was basically all over her body at that point and it looked like kind of raised welts so at that point they did take her to the hospital for them to evaluate her and after taking down all of her medical history they doesnt believe that it doesnt seem consistent with like a food allergies or something that she had consumed, with usual like you change soaps and basically but the doctors ended up thinking that it possible that she is having like adverse reactions with the vaccine.   Follow-up attempts are completed. No further information is expected.