Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: headache; fever was high and it was 103.2 degrees; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team and product quality group 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 11:30 (Lot number: FE3594) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot FH8027, patient's card has no expiry dates or NDC numbers written on it.), administration date: 28Nov2021, when the patient was 12 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19Dec2021, outcome "recovered" (20Dec2021), described as "headache"; PYREXIA (non-serious) with onset 19Dec2021, outcome "recovered" (20Dec2021), described as "fever was high and it was 103.2 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: After 12 hours of getting the vaccine reporter son had fever and headache which are resolved already. Her son was tested on Monday 20Dec2021 and he was positive in the PCR test. Per caller, her son have had subsequent PCR test that were all negative within the last 3 days. Reporter was looking for studies or information on patients who were tested positive 24 hours after receiving the vaccine. The report related to a study or programme. states he has a HCP calling to report an adverse event for her own 12 year old son and the patient got his 2nd dose of the Pfizer Covid vaccine on Sunday 19Dec2021 and they are going on vacation and she got the patient tested on Monday 20Dec2021 and he was not a big kid and she wanted to get him the Pfizer COVID Vaccine for 12 year old 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; states they are going on vacation and are supposed to leave and the patient had a PCR test and he wass the only person to test positive for the PCR test. Reporter states she did subsequent PCR tests on the patient and they were all negative in the last three days; states 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; states the Regulatory Authority has the patient on a no fly list and she is seeking information about this. Transferring agent states the caller said she does not know how to get the patient off the list and the patient does not have covid anymore. Reporter verified the information provided by the transferring agent and states she will do whatever it takes to get her help with the Regulatory Authority and the patient was tested to go on a trip and he was vaccinated the day before with the Pfizer Covid vaccine and she searched and searched and is asking if there are any studies done with the PCR coming up positive within 24 hours timeframe of receiving the Pfizer Covid vaccine. Reporter states she knows theoretically this can't happen and there is no live virus in the vaccine but she does not know and there are no studies. Reporter states 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; states the patient never had symptoms of anything and did an at home test on Wednesday before and did an at home test that was negative just because this is so rampant and then she has gotten him three PCR tests in the past 24 hours and they have all been negative; states she did research to see about this and she believes in science and they are not giving live vaccine and the vaccine can't give you covid but it is all so new and so is the testing and there is not information and it had to be something if you do have a reaction and can the reaction cause the test to be positive. Reporter asks if people who get fevers have they all been tested 24 hours after the Pfizer Covid vaccine with a PCR test. Vaccination facility type was school. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Reporter states the patient had the 1st dose of the Pfizer Covid vaccine on 28Nov2021 with lot FH8027, had the 2nd dose on 19Dec2021 with lot FE3594 and the patient's card has no expiry dates or NDC numbers written on it. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine reported as none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) reported as none. States she gave the patient Tylenol and the fever and headache resolved and the Tylenol was administered after the vaccination. States 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. Reporter states for seriousness criteria for the patient's reported events, his fever was high and it was 103.2 degrees and she is not one who worries so she would say this is not serious for the fever, headache and positive PCR test. Reporter asks if all people that have reactions are tested and do the tests come back positive because of the reactions and she knows the vaccine can't give covid but she is desperate and looking for a way. States she is looking for something from Pfizer that says this could be reportable and that it has been seen before so she can submit it and he has had negative test results and it could be from the Pfizer covid vaccine that he tested positive so he can be taken off the list. Description of complaint: Vaccine Supplemental Form completed in additional context. States her own 12 year old son and the patient got his 2nd dose of the Pfizer Covid vaccine on Sunday 19Dec2021 and they are going on vacation and she got the patient tested on Monday 20Dec2021 and he is not a big kid but is 70 pounds and she 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; states they are going on vacation and are supposed to leave and the patient had a PCR test and he is the only person to test positive for the PCR test. Reporter states she did subsequent PCR tests on the patient and they were all negative in the last three days; states 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; states the Regulatory Authority has the patient on a no fly list and she is seeking information about this. Transferring agent states the reporter said she does not know how to get the patient off the list and the patient does not have covid anymore. States the patient never had symptoms of anything and did an at home test on Wednesday before and did an at home test that was negative just because this is so rampant and then she has gotten him three PCR tests in the past 24 hours and they have all been negative; states she did research to see about this and she believes in science and they are not giving live vaccine and the vaccine can't give you covid but it is all so new and so is the testing and there is not information and it had to be something if you do have a reaction and can the reaction cause the test to be positive. Caller asks if people who get fevers have they all been tested 24 hours after the Pfizer Covid vaccine with a PCR test. Reporter an HCP Calling about an Adverse Event so he has gotten her 12-year-old his second vaccine on Sunday and was going on a vacation and I got him tested on Monday. he's not a big kid he's 70 pounds but they wanted to get the 12-year-old vaccine and then 12 hours later the side effects he had fever, headache, and then within a couple of hours he get better.   Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer-BioNTech Covid-19 Vaccine Injectable lot FE3594 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FE3594, fill lot FF2555, and the bulk formulated drug product lot EY0909. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. ID of Previously Completed Inv: 6666659 and Link (Previously Investigated CR): 6666477.      Follow-up attempts are completed. No further information is expected.