Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: vaccine be authorized for use in children < 12 years of age; vaccine be authorized for use in children < 12 years of age; her arm was sore for 2 hours; This is a spontaneous report from a contactable consumer. A 10-years-old female patient received bnt162b2 (Formulation: Solution for injection; Solution for injection; Batch/Lot number was not reported), dose 1 intramuscular, administered in Arm Left on 14Jul2021 18:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from 2011 to an unknown date (Asthma at one year old), vertigo from 2013 to an unknown date (Vertigo diagnosed at age 3), migraine from 2016 to an unknown date (Childhood Migraines diagnosed at age 6). She mentioned that patient sees a neurologist for her migraines. She was in an accident and had a concussion and then developed migraines after that. Peanut allergy and no other allergies. Got into peanut butter as a baby under 3 months old. She just got swollen and did not have to go to the hospital. They ended up taking her because they did not know, and it was gone by the time she was there. They advised to stay away from peanuts because she had that small reaction. She did not stop breathing or anything. For a 10-year-old she has already started her puberty and menstrual cycle. So, she is like a 12-year-old. She did not know how they based their clinical trials for children 12 and older receiving the vaccine. She said they may have decided to base it on 12-year-olds because of puberty. She is an early developer and she linked her with the 12 years old group because of this. She is due to have her 11 years old vaccine in Sep and cannot have them until after 24th when her actual birthday is. That would include Meningitis, Meningococcal and it is 3 different ones that she is supposed to get once she turns 11. It will be over 6 weeks apart and that is what she wanted to get 2nd shot since those other vaccines are coming up 8 weeks later. If she does it now before school starts, it will be better, so she won't be so close together. She wanted to know regarding second shot, of the 11-year-old age group, did they have more or the same side effects as normal adult's side effects. She then stated previous agent kind of tried to answer, but he was not able to answer. He was asking question from someone else. The patient's concomitant medications were not reported. Caller asked further on the safety of the vaccine for children. Caller mentioned her daughter (Patient) had the first Pfizer-BioNTech COVID-19 Vaccine dose. Patient did not experience any side effect except that her arm was sore for 2 hours. It went away afterwards. Patient did not get her second dose yet, because Caller wanted to make sure that it will be safe for her age. Patient is 10 years old. Caller stated that Patient already started her puberty similar to that of a 12-year-old. Caller wanted to know the possible side effects for her daughter's age group (5-11 years old), particularly for the second dose. Reporter confirmed information above. She did not wish to provide her mailing address or email. She wants her daughter to get second dose and does not want anybody coming after her. She did not wish to provide her daughter's primary care provider's contact details. She said patient's arm was not sore at first, it was just a little pain. It occurred a little later and then lasted 2 hours and went away. When the pharmacist gave her the injection, he looked for a spot very carefully on her arm. He was trying to get the meatiest part of her arm. She said kids age 12 or whatever, they have less standing tissue. He was very careful. She believes it was given in the muscle because he was careful to get it in the right spot and he is a professional that gave it. She is due for second shot 04 Aug 2021. She has underlying health conditions such as Asthma, Vertigo and childhood migraines. She spoke with a physician and wanted to know if it would be good for her to get it because of this. There was a pass for 12 years old and the child would be safer without it because if you have COVID, you could end up in the hospital or dead. She has already gone to school. She was online school for 2 years and wants her to get back to normal. She mentioned that patient sees a neurologist for her migraines. She does take other medication but did not think it was relevant to report since she was only sore for a couple of hours. She was in an accident and had a concussion and then developed migraines after that. Left arm sore couple hours after she got the vaccination, and she does not remember the time. It was not hurting but was just sore like anyone else would have. The outcome of the events was unknown.  Information on the lot/batch number has been requested.