Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Inappropriate schedule of product administration, Pruritus, Vaccination site erythema
Clinical narrative: First dose was on 01/19 of 22 (19 Jan 2022); second Pfizer COVID-19 Vaccine yesterday (23 Sep 2022); injection site swelling; injection site redness; rather large in size, the redness; it is itching her but she is scratching at it; little warm to the touch; it is itching her but she is scratching at it; little warm to the touch; Diarrhea; Decreased appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 8-year-old female patient received BNT162b2 (BNT162B2), on 23Sep2022 as dose 2, single (Lot number: FL9095) at the age of 8 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, single, lot number: FL8095), administration date: 19Jan2022, when the patient was 7-year-old, for COVID-19 Immunization. The following information was reported: DECREASED APPETITE (non-serious) with onset Sep2022, outcome "unknown"; DIARRHOEA (non-serious) with onset Sep2022, outcome "unknown", described as "Diarrhea"; VACCINATION SITE ERYTHEMA (non-serious) with onset Sep2022, outcome "unknown", described as "injection site redness; rather large in size, the redness"; VACCINATION SITE SWELLING (non-serious) with onset Sep2022, outcome "unknown", described as "injection site swelling"; PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Sep2022, outcome "unknown" and all described as "it is itching her but she is scratching at it; little warm to the touch"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 23Sep2022, outcome "unknown", described as "First dose was on 01/19 of 22 (19 Jan 2022); second Pfizer COVID-19 Vaccine yesterday (23 Sep 2022)". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site erythema, pruritus, vaccination site warmth, diarrhoea, decreased appetite.  Additional information: The COVID-19 vaccine was a pfizer product. NDC, UPC number and expiry date of COVID-19 Vaccine was unknown. The reporter stated, "My daughter she is 8 years old, she had her second Pfizer COVID-19 vaccine yesterday (later date of vaccination of second dose clarified as 23Sep2022) at her pediatrics and I was just reading over the paperwork. She has just some, she has just a couple of the side effects that are listed on the paperwork and I just happen to see where you know, it said to go ahead and report those and so, I thought I would call in and do that. She has the injection site swelling and injection site redness. This I do not think is listed but it is itching and it is a little warm to the touch, if I touch it you know, sort of warm but it is itching her but she is scratching at it you know and it is rather large in size, the redness. She seems to have a decreased appetite that she has had. She had very 'little' diarrhea all morning since she is been up probably at, she has been up since probably 7:30 am and probably it started at about, I would say 9 am and it is 12:30 pm here so I believe it is well, I am not sure, I think we are eastern standard time I am not sure. Probably she had that for about 3 and half hours." Reporter stated, "She did had the injection in her leg this time she went ahead and had it, last time it was in her arm. She went ahead and just got it in her leg this time so you know, if that is makes a difference. We did that just because she was getting a flu shot (Further not clarified hence suspect captured as Unspecified Shot) too and we had it put in her other leg and just because you know her walking around and stuff we thought that. You know it might cause less pain say of the flu shot and being in the other leg. So, we just got one put it in each leg so, that was you know the reason for that." Reporter stated regarding lot details that, "The first dose was FL8095 and this dose yesterday was FL9095 (clarified as lot# of second dose). Yes, I am trying to see if, because I am trying to read yes, because it would not be the same for sure. I am trying to read the nurse's handwriting and it has to be 9095, it could not be 8095 for the second one, right. Right, they could not be the same dose# right." Patient did not have any medical condition and was not taking any concomitant medications. Reporter stated, "No laboratory test. She was actually there just for her 8 year old wellness checkup and just went ahead and got the vaccinations while we were there. Treatment for AE; Reporter stated, "No and like I mentioned though she did get her flu vaccination yesterday as well in her other leg. He did not have the lot number available with him."  Follow-up attempts are completed. No further information is expected.