Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: fever 99 to 100.5; Lethargic; Patient Age: 10 years old; Patient Age: 10 years old; very sore throat; loss of appetite; tired; Sleepy; cough; This is a spontaneous report received from 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 (COMIRNATY), administered in arm left, administration date 11Nov2021 17:05 (Batch/Lot number: unknown) at the age of 10 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Nov2021 17:05, outcome "unknown" and all described as "Patient Age: 10 years old"; PYREXIA (non-serious) with onset 12Nov2021, outcome "not recovered", described as "fever 99 to 100.5"; LETHARGY (non-serious) with onset 12Nov2021, outcome "unknown", described as "Lethargic"; OROPHARYNGEAL PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "very sore throat"; DECREASED APPETITE (non-serious) with onset Nov2021, outcome "unknown", described as "loss of appetite"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "tired"; SOMNOLENCE (non-serious) with onset Nov2021, outcome "unknown", described as "Sleepy"; COUGH (non-serious) with onset Nov2021, outcome "unknown", described as "cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, lethargy, oropharyngeal pain, decreased appetite, fatigue, somnolence, cough.  Caller was a consumer inquiring about side effects of the Pfizer Covid-19 vaccine (orange top). Caller is calling on behalf of his son (10 years old, male). Caller reported that he was transferred from Pfizer line and provides reference number. Caller stated my son received the vaccine for that age group last Thursday about 5pm. It was phenomenal, he didn't even know when they put it in his arm, no site pain, redness, life was magnificent almost like the flu shot, but 22 hours later he developed a fever, he was lethargic. Now were 5 days post and we still have to medicate with acetaminophen and ibuprofen. He was having cough, loss of appetite, sore throat. He tested negative for strep and covid and we're trying to rule stuff out. Caller asked would this be a common side effect of the vaccine. Caller reported that he was in a clinical trial and also tried to put his son in one as well. He reports that they are pro-vaccine. Caller stated that I was surprised that this would not be an uncommon side effect, it's far worse than anyone else we know that got it. Description of Product Complaint: He was calling about the 5 to 12 year old COVID vaccine. His son was eagerly waiting to get it and got it at 5:05PM last Thurs-day, 11Nov2021. He had zero soreness. He didn't even feel it go in. He had no site pain. No swelling or redness. It couldn't have gone better. Caller was not saying it related and is asking, but 22 hours later his son got fever and felt lethargic. That was Friday, 12Nov2021. Now it is Tuesday and he still has to be medicated with Ibuprofen and Acetaminophen to keep fever down. He has been tested for strep and it was negative. Tested for COVID with spit test and it is negative. That test is supposed to be very ac-curate. He has a very sore throat. If he is not medicated with over the counter he has a loss of appetite and is tired, sleepy, and lethargic. With the medication it is just keeping his fever 99 to 100.5. Has that been associated with the 5 to 12 years old COVID Vaccine. Caller clarified that his son is eating well and not lethargic when the fever is down. He has sore throat and runny nose. Acetaminophen: caller was giving him 500mg, but last night switched to the extended release. Caller thinks the extended release only comes in one strength. It is either 650mg or 625mg. It is the 8 hours. He is taking it three times a day. Ibuprofen: 300mg twice a day. Doesn't have NDC, lot, and expiry to provide. For (LOCATION) Only: Vaccina-tion Facility Type: Family Practice Doctor. His daughter is (PRIVACY). Over a third of the people that it was given to didn't show up for work. It's was the sickest he has seen her. Caller stated that he had been home all day with a sick kid and if he could just be transferred for his question he would appreciate it.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.