Age: 6.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autism spectrum disorder, Poor quality product administered, Product storage error, Social anxiety disorder, Therapeutic product effect variable
Clinical narrative: child had high functioning autism. He had oral and auditory symptoms, and speech symptoms including a stutter.; her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours; social anxiety; efficacy issue; her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 08:45 (Lot number: FK5127) at the age of 6 years 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: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "child had high functioning autism. He had oral and auditory symptoms, and speech symptoms including a stutter."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021 08:45, outcome "unknown", PRODUCT STORAGE ERROR (non-serious), outcome "unknown" and all described as "her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours"; SOCIAL ANXIETY DISORDER (non-serious), outcome "unknown", described as "social anxiety"; THERAPEUTIC PRODUCT EFFECT VARIABLE (non-serious), outcome "unknown", described as "efficacy issue". The nurse said in the state of (state withheld), they have reported this same situation 3 times. It was beyond 12 hours. The patient did not have an official diagnosis of autism disorder, but mother thought her child had high functioning autism. The patient had appointment at 08:30 so he probably received the vaccine at 08:45. The nurse said it was just an efficacy issue. The nurse said everything was fine, and that he wouldn't have to get a 3rd shot. It was out of the 12 hour window. He is to return 10Dec2021 for his second dose. He got it in his right arm. There was nothing medically connected to it. She was just fearful of him might having autism and vaccines. The vaccine was not administered at Military Facility. The patient did not have previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit emergency room and physician office. The patient did not have prior vaccinations (within 4 weeks). The patient did not have diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have following tests: blood tests, cerebrospinal fluid culture, bacterial sero-type and diagnostic imaging (e.g., chest X-ray, MRI).  Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.