Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Nasopharyngitis, Rash erythematous
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). A 5 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Mar2022 (Lot number: SL0007, Expiration Date: 15Apr2022) at the age of 5 years as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "COVID"; RASH ERYTHEMATOUS (non-serious) with onset 08Mar2022, outcome "recovered" (Mar2022), described as "Rash/showed pictures of the rash and it does not look like hives, but erythematous/redness in thigh and butt cheeks"; SKIN EXFOLIATION (non-serious) with onset 21Mar2022, outcome "unknown", described as "his hands and feet are peeling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08Mar2022, outcome "unknown", described as "Redness at injection site"; FATIGUE (non-serious) with onset Mar2022, outcome "unknown", described as "acted a little tired/not feeling himself from the trip/over tired"; NASOPHARYNGITIS (non-serious) with onset Mar2022, outcome "unknown", described as "thought he was coming down with a cold". Clinical Course: Pediatrician reported COVID vaccine administered to 5-11 year old patient. She gave a little boy the vaccine about 2 weeks ago and the mom came in. She later stated the patient did not come in but the mom had pictures. The next day after he got the vaccine, he did not have a fever, but developed a rash. Dad was a paramedic and thought that maybe since they had been to and played in snow and maybe it wasn't due to COVID. The only other thing he had was he acted a little tired, but they said to expect it because their other kids were tired. This was the only other reaction with the kids. She was just asked because she showed pictures of the rash and it does not look like hives, but erythematous and went away. The vaccine was given on 07Mar2022, his hands and feet were also peeled and she was wondering if that was something that has been documented. Most of the time when kids have hand foot mouth with a virus, their hands would peel. So, she was not sure if this was a normal thing. It was within 48 hours of giving it. He was not feeling himself from the trip and was over tired and thought he was coming down with a cold, but the dad who was paramedic, wanted him to get the shot and scheduled it. He waited the 15 minutes and went well and had no problems. The mother said he had redness at injection site. That was not while he was in her office. She was not sure if it was 20, 22, or 24 hours after when he developed the rash. The pictures that she showed her were of redness, she did not bring him in. She did not see him. It looked like redness in thigh and butt cheeks, but it was given IM in the left deltoid. The patient's age was 5 years and 2 months. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the event Drug ineffective and Covid-19 cannot be completely excluded.