Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he was positive in the PCR test.; he was positive in the PCR test.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 (Lot number: FE3594) at the age of 12 years as dose 2, single and administration date 28Nov2021 (Lot number: FE3594) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2021, outcome "recovered" and all described as "he was positive in the PCR test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: subsequent PCR test that were all negative within the last 3 days; (20Dec2021) positive, notes: tested on Monday 20Dec2021 and he was positive in the PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: the reporting parent stated that the patient received the 2nd dose of Pfizer-BioNTech Covid19 Vaccine on 19Dec2021. After 12 hours of getting the vaccine the patient had fever and headache which are resolved already. The patient was tested on Monday 20Dec2021 and he was positive in the PCR test. The patient had subsequent PCR test that were all negative within the last 3 days. The reporter was looking for studies or information on patients who were tested positive 24 hours after receiving the vaccine. It was mentioned that they were going on vacation and they got the patient tested on Monday 20Dec2021 and he was not a big kid but was 70 pounds and she (reporter) wanted to get him the Pfizer COVID Vaccine for 12 year olds so he got it and then 12 hours later he had the side effects of fever and headache and that was within a couple of hours of having the vaccine 2nd dose; stated they were going on vacation and were supposed to leave and the patient had a PCR test and he was the only person to test positive for the PCR test. She has searched to see if there are any studies done of people having positive tests within 24 hours of getting the vaccine and the vaccine causing positives but she does not know; stated the (privacy) has the patient on a no fly list and she was seeking information about this. The reporter stated that she does not know how to get the patient off the list and the patient does not have covid anymore. It was added that they did the PCR test because they are going on vacation and her entire family were all negative for the PCR test except for the patient. The patient never had symptoms of anything and did an at home test on Wednesday before that was negative just because this was so rampant and then she had gotten him three PCR tests in the past 24 hours and they have all been negative. She asked if people who get fevers have they all been tested 24 hours after the Pfizer Covid vaccine with a PCR test. There were no additional vaccines administered on same date of the Pfizer vaccine. It was mentioned that the patient was given Tylenol and the fever and headache resolved and the Tylenol was administered after the vaccination. The patient's fever and headache began literally 12 hours later after his 2nd dose of the Pfizer Covid vaccine and she checked his temperature and it was 103 degrees so she gave him Tylenol and he had no fever by morning and he had a headache that Monday and with the Tylenol it resolved completely. The reporting parent stated for seriousness criteria for the patient's reported events, his fever was high and it was 103.2 degrees and she was not one who worried so she would say this was not serious for the fever, headache and positive PCR test. The reporter considered the event as related to Pfizer Covid vaccine.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective cannot be ruled out.