Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vision blurred
Clinical narrative: headache; blurred vision; Light headedness; feeling horrible/ he is not feeling well; fever; Fever was reported as worsened; chills; This is a spontaneous report from a contactable consumer (parent) via medical information team. A 12-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Lot number: FD8448/Batch number was not reported) via an unspecified route of administration, administered in right arm on 08Sep2021 11:13 AM (at the age of 12 years) as dose 1, single dose for covid-19 immunization and adalimumab (HUMIRA), via an unspecified route of administration from 08Sep2021 evening (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for crohn's disease. The patient took his Humira 2 weeks ago and then he had a dose of it yesterday because it was time for it again. The patient's medical history included crohn's disease from Apr2019 to an unknown date. The patient's concomitant medications included methotrexate (METHOTREXATE), 2.5 mg weekly, folic acid (FOLIC ACID) 1000 ug 1 per day, dicyclomine (DICYCLOMINE) 10 mg per day, cyproheptadine (CYPROHEPTADINE) 4mg per day at night taken for an unspecified indication, start and stop date were not reported. No previous immunization with the Pfizer vaccine considered as suspect. Prior Vaccinations within 4 weeks reported as none and no adverse events following prior vaccinations. Additional vaccines administered on same date of the Pfizer suspect reported as none. On 09Sep2021, the patient experienced fever, light headache, blurred vision, feeling horrible or he is not feeling well and light headedness, on an unspecified date in Sep2021, experienced fever was reported as worsened. It was reported that in a clinical study, adverse reactions in adolescents 12 through 15 years of age included headache (75.5%), and fever (24.3%). Advised caller that there in no information on blurred vision as an adverse event after getting the Pfizer Biontech Covid-19 Vaccine. It was reported that side effects that patient may experience throughout the rest of his body (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Reporter stated that the patient had the vaccine yesterday and he has Crohn's so the doctor recommended he get it. Today the patient is running a fever. The patient got his Humira shot last night and that is the caller's concern. The patient also has blurred vision and is lightheaded. The patient had the vaccine yesterday and woke up this morning feeling horrible. The caller called the patient and he said he is not feeling well. The patient got up to get drink and was light headed and had blurred vision. The caller came home and gave the patient some soup and Gatorade. This morning the patient's fever was 99.0 and when she came home it was 100.6. Reporter inquired that the patient has been on Humira for almost 2 years and never had this problem and also questioned this was a reaction with Humira. The patient said that the lightheadedness and blurred vision wasn't as bad as it was. Adverse events did not result in a visit to the emergency room and physician office. The patient underwent lab tests and procedures which included body temperature included high temperature (fever) on unspecified date, 99.0(fever) on unspecified date, 100.6 (fever) on unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of the events was light headedness, blurred vision was recovering, headache, feeling horrible or he is not feeling well and fever was reported as worsened was unknown and for fever it was not recovered or not resolved and chills recovered on unspecified date in Sep2021.   Follow-up attempts are completed. No further information is expected.