Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Product administration error, Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Missed the deltoid muscle and gave it too low, below the deltoid muscle; Missed the deltoid muscle and gave it too low, below the deltoid muscle; feel soreness in the muscle where you have the shot /felt a little bit; Bandage was 80-90% blood covered; 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 10-year-old male patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), administration date: 2021, when the patient was 10 years old, for COVID-19 Immunization, reaction(s): "Sore muscle", "Little bleeding". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 03Dec2021, outcome "unknown" and all described as "Missed the deltoid muscle and gave it too low, below the deltoid muscle"; VACCINATION SITE PAIN (non-serious) with onset 03Dec2021, outcome "unknown", described as "feel soreness in the muscle where you have the shot /felt a little bit"; VACCINATION SITE HAEMORRHAGE (non-serious) with onset 03Dec2021, outcome "unknown", described as "Bandage was 80-90% blood covered". Additional information She states her 10-year-old son got his second dose last Friday 03Dec2021.  The pharmacy missed the deltoid muscle and gave it too low, below the deltoid muscle. She is asking does he need to be revaccinated, does he need to repeat the second dose. He adds: After the first dose his son had a sore muscle but this time no soreness and then the next morning, he felt a little bit.  After the first dose he had very little bleeding, but after second dose the bandage was 80-90% blood covered and when they did the shot, they did not do at the recommended location on the center of deltoid. They missed the muscle completely and in the lower part, like in the middle of the upper arm where they missed the muscle and when I take of the band-aid I noticed a lot of bleeding than expected. So, my son did not feel like this in the first shot. He feels soreness in the muscle where you have the shot and then the bleeding become more and more intense. At that time in the beginning, he did not feel anything at all and the later in the morning, the next day he feel little bit of soreness. So, my concern is I do not know if this is the, because the location is not correct will there be any compromise to the protection against COVID. Reporter stated, "No side effects, it is just that it missed at the wrong place. I do not know if there will be a side effect. Right now, does not seem like it. I just need to know if it is effective or not. I would like to skip it." Reporter was unwilling to complete the report. Thus, further probing could not be done. Hence, limited information was available over the call. Question: What about antibody testing- is that for patients who got Covid 19. Response: Stated I cannot speak to the use of antibody test for prior Covid 19 patients.  I can only speak regarding the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.