Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error, Pyrexia, SARS-CoV-2 test
Clinical narrative: had aches and pains; fever of 102.2 degrees; The vial was not diluted before drawing up the dose and he received the contents of the vial as a single injection - approx. 150-180 mcg.; The vial was not diluted before drawing up the dose and he received the contents of the vial as a single injection - approx. 150-180 mcg.; myalgia; depression has gotten worse; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Dec2021 12:00 (Lot number: FJ8757) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 22Dec2021 12:00, outcome "unknown" and all described as "The vial was not diluted before drawing up the dose and he received the contents of the vial as a single injection - approx. 150-180 mcg."; PAIN (non-serious) with onset 23Dec2021, outcome "unknown", described as "had aches and pains"; PYREXIA (non-serious) with onset 23Dec2021, outcome "unknown", described as "fever of 102.2 degrees"; MYALGIA (non-serious) with onset 22Dec2021, outcome "recovered" (24Dec2021), described as "myalgia"; DEPRESSION (non-serious) with onset 22Dec2021, outcome "not recovered", described as "depression has gotten worse". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: The patient received his first covid vaccination with Pfizer vaccine. The vial was not diluted before drawing up the dose and he received the contents of the vial as a single injection - approx. 150-180 mcg. AE resulted in Prolongation of existing hospitalization (vaccine received during existing hospitalization). The patient was not diagnosed with COVID-19 prior to vaccination. The patient been tested positive for COVID-19 after vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. No known allergies reported, and device date was 07Feb2022.  Follow-up (08Feb2022): This is follow-up spontaneous report from a contactable Physician. This Physician reported for the patient in response to HCP letter sent to physician via telephonic follow-up activity which Updated information included: Salutation added, lab data, Title Dr added in Doctor, Health Care Professional Information. New events added. Product license updated.  Additional information: The patient was in the hospital for behavioural health issues and depression already, and was offered the vaccine. That is when the overdose incident occurred. He was released home that next day. He had one extra day of myalgia on second day after the overdose, and by third day was back to normal. His depression has gotten worse after the date of the vaccine although it was pre-existing before the vaccine. The parents have asked the physician about long-term issues and what to worry about and when to get the second dose. I provided the physician with the phone number for medical information.