Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 (Lot number: FL0007) at the age of 10 years as dose 2 , single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII, administration date Oct2020. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: F145816, Location of injection: Arm Left), administration date: 26Nov2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Dec2021, outcome "recovered" (Dec2021), described as "Sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The reporter was reported did not had Seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization , Disabling/Incapacitating  and Congenital anomaly/birth defect. The reporter was told dose 2 received  and product COVID-19 its Pfizer brand . The unknown of LOT and Previous vaccination details. The patient had other vaccine in four weeks details of product was Flu vaccine. Then no List of any other medications the patient received within 2 weeks of vaccination. The patient had  Event Sore arm for treatment was used ibuprofen. Their was no  Prior to vaccination, was the patient diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19. The Pfizer Drug safety unit recently received the attached report submitted by you via  Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date was  the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. The reporter was told wrong dates  adverse event  Sore arm was start date: 11Dec2021.The correct dates for the second dose was 17Dec2021. The date that the sore arm started was 18Dec 2021.The reporting adverse event information to Safety on (database) 21Dec2021. Pfizer Safety hopes that the child is feeling much better now. As Per below screenshot, you confirmed the event onset as 18Dec2021 and the information was entered as document 18Dec2021 database 21Dec2021. We were  actioned to follow-up on any delayed AE reports for compliance reasons. Please kindly confirm your first Awareness Date (document), as the first Pfizer agent to receive this information. If the information was reporting outside of the 24 hour compliance period for AE reporting, kindly provide a reason for the delay in reporting and confirm your completion of certification AE reporting training. The reporter had no real reason for the delayed reporting. The  just wasn't thinking. He's gotten sore arms in the past from other routine vaccinations .The patient  didn't think much of it, it wasn't until a few days later .The  remembered this was from the covid vaccine made by Pfizer. He needed to report  thought it was better to report it late than not at all. The  apologize for the delay, he know it should have been within 24 hours  will make sure to do so if it happens again. The reported Vaccine administered at facility. The 3rd dose was administered were not applicable. The unknown details of Dose 3. The Prior history of sore arm at injection site with routine childhood vaccinations. Their was no Specific relevant test for thromboembolic events with thrombocytopenia. He received his vaccine Friday evening. On Saturday he complained of a sore arm . The pain in his arm woke him up early Saturday morning. We gave him OTC children's ibuprofen for pain relief 3 times on Saturday because his arm hurt so much. It was better on Sunday  and then he was fire on Monday. Other than the sore arm he had no other AEs.  Follow-up (22Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported in response to a query sent which included that: Updated information: Start date of 2nd dose and AE onset date.  Follow up (29Dec2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query which included that:  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.  Follow-up (04Jan2022) : This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Updated information included : Dose description, Product coding, Reporter suffix.  Follow-up (18Jan2022): This is a spontaneous follow-up report received from a contactable consumer. This Consumer reported in response to Non-HCP letter sent via follow-up letter that included:  No follow-up attempts are possible. No further information is expected.