Sex: M
Vaccine: COVID19
Symptoms: Asthma, Influenza virus test, Off label use, Product use issue, Respiratory syncytial virus test
Clinical narrative: Asthma exacerbation; Vaccine Name: Gardasil; Date: 11Aug2022; Vaccine Name: Gardasil; Date: 11Aug2022; This is a spontaneous report received from contactable reporter(s) (Nurse), Program ID.  A 9-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2022 as dose 1 (orange cap), 0.2 ml single (Lot number: FL8094), in right deltoid for covid-19 immunisation; hpv vaccine vlp rl1 4v (yeast) (GARDASIL), on 11Aug2022 as 0.5 ml, single (Lot number: U019413) intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Asthma", start date: 2015 (ongoing); "Allergies to peanuts", start date: 2015 (ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 11Aug2022, outcome "unknown" and all described as "Vaccine Name: Gardasil; Date: 11Aug2022"; ASTHMA (hospitalization, medically significant) with onset 23Aug2022, outcome "recovering", described as "Asthma exacerbation". The patient was hospitalized for asthma (start date: 23Aug2022, discharge date: 25Aug2022, hospitalization duration: 2 day(s)). The event "asthma exacerbation" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Influenza virus test: (23Aug2022) Negative, notes: Result: Negative; Unit: Not Provided; Respiratory syncytial virus test: (23Aug2022) Negative, notes: Result: Negative; Unit: Not Provided; SARS-CoV-2 test: (23Aug2022) Negative, notes: Result: Negative; Unit: Not Provided. Therapeutic measures were taken as a result of asthma as the patient was started on oral steroids.  Clinical Course: The call initially was regarding a Temperature Excursion involving Pfizer Covid-19 Vaccine, gray cap monovalent and Pfizer Covid-19 Vaccine, orange cap. The minimum temperature reached was 1.1 degrees Celsius for 35 minutes. The products were inside the refrigerator. She confirmed the vaccines were unpunctured with no prior temperature excursions. She mentioned that there was a 9 year old male patient who received the Pfizer Covid-19 Vaccine, orange cap at around 16:00 and they were able to check the data logger at 17:00 but they were not sure if the patient received the product after or before the temperature excursion occurred. Caller verified information provided. The dose administered potentially involved in the temperature excursion was the patient's second dose. Clinical course: Nurse mentioned that the patient was hospitalized for asthma exacerbation on 23Aug2022, after having received the first dose of the Pfizer Covid-19 Vaccine, orange cap on 11Aug2022. She asked if the patient is going to be ok, is there any monitoring they should be doing. She explained this was addressed by agent who advised her to consult with the CDC. She was told the vaccine was stable at 1.1 when she gave it, but they don't know if the vaccine was given to this patient before or after the excursion. Asthma exacerbation has historically been seen multiple times in the clinic for this condition. He was seen in urgent care initially on 23Aug2022 related to this event, and hospitalized same date. Regarding treatment and medical interventions the patient was started on oral steroids relative to the asthma exacerbation event. He is being seen by pulmonologist and doing much better post-admission on medications. Additional Vaccine administered on same date was reported as Gardasil.