Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity, Product leakage, Syringe issue, Underdose
Clinical narrative: At the time of the administration, the liquid leaked outside of the syringe; At the time of the administration, the liquid leaked outside of the syringe; At the time of the administration, the liquid leaked outside of the syringe; arm was sore; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 7 year-old male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 26Nov2021 15:32 (Lot number: FK5127, Expiration Date: 31Jan2022) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Reactive airways disease", start date: 06Nov2019 (ongoing); "seasonal allergic rhinitis" (unspecified if ongoing), notes: The patient had seasonal allergic rhinitis due to pollen and drug allergies.; "Pollen allergies" (unspecified if ongoing), notes: The patient had seasonal allergic rhinitis due to pollen and drug allergies.; "multiple aero allergens" (unspecified if ongoing), notes: He has multiple aero allergens. Concomitant medication(s) included: FLU taken for immunisation, start date: 05Nov2021, stop date: 05Nov2021; PROVENTIL [SALBUTAMOL SULFATE] taken for bronchial hyperreactivity. Past drug history included: Amoxicillin, reaction(s): "hives", notes: amoxicillin says serum sickness and the reaction is hives and the reaction to cefdinir is a rash; Cefdinir, reaction(s): "rash", notes: amoxicillin says serum sickness and the reaction is hives and the reaction to cefdinir is a rash. Vaccination history included: Flu shot (She later provided that Last year in 2020 he had a flu shot and the following Thursday he woke up with hives and urticaria on his arms. His mother gave him Benadryl and the hives turned and got much worse on his face, trunk, arms and legs then the mother gave him antihistamines and took him to the children's emergency room at that time. It all improved with antihistamines and there were no systemic issues present.), administration date: 2020, when the patient was 6 years old, for Immunization, reaction(s): "Hives and urticaria". The following information was reported: UNDERDOSE (non-serious), SYRINGE ISSUE (non-serious), PRODUCT LEAKAGE (non-serious) all with onset 26Nov2021 15:32, outcome "unknown" and all described as "At the time of the administration, the liquid leaked outside of the syringe"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "arm was sore". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: Causality: She believes that this is unrelated because she thinks that she would have heard about other incidents. She is thinking maybe something was wrong with their needle and maybe it was not connected well. History/ Investigations: The patient is using inhalers and it is originally reported that he has asthma because she sees that there is an asthma action plan in his chart. He is using the ProAir Proventil inhaler. Caller later clarifies that the patient does not have asthma, he has reactive airway disease. Inquired for the Inhaler start date and dosage and caller did not provide these when requested.  Description of Product Complaint: Description of complaint: Caller, a nursing supervisor/ registered nurse, reporting AEs following a patient orange cap pediatric dose Pfizer COVID vaccine mentioned that previously after the patient had a flu shot he had woke up with hives and urticaria on his arms and then his mother gave him Benadryl and the hives turned and got much worse.   No follow-up attempts are possible. No further information is expected.