Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Lethargy, Nausea, Pyrexia, Vomiting
Clinical narrative: severe stomach pain; Nausea; Vomiting; Fever; Lethargy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient. The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow up information on 01Feb2022, this case contains serious adverse reaction(s) and all safety information is processed together.  A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 13:15 (Lot number: FK5618) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Padiatric pfizer (Dose 1, Batch/Lot No: FK5127, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM, Route of administration: Intramuscular), administration date: 12Nov2021, when the patient was 7 years old, for Covid-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (medically significant) with onset 06Dec2021 07:30, outcome "recovered" (Dec2021), described as "severe stomach pain"; LETHARGY (non-serious) with onset 05Dec2021 07:00, outcome "recovered" (06Dec2021), described as "Lethargy"; PYREXIA (non-serious) with onset 05Dec2021 08:00, outcome "recovered" (06Dec2021), described as "Fever"; NAUSEA (non-serious) with onset 06Dec2021 07:30, outcome "recovered" (06Dec2021 13:00), described as "Nausea"; VOMITING (non-serious) with onset 06Dec2021 07:30, outcome "recovered" (06Dec2021 13:00), described as "Vomiting". Therapeutic measures were not taken as a result of lethargy, pyrexia, nausea, vomiting. No other vaccine in four weeks and no other medications in two weeks. The patient did not experienced covid prior vaccination. The morning after second dose of vaccination 05Dec2021 patient had fever starting in the morning (approximately 8:00 AM) continuing through the day until bed time (approximately 8:00 PM), lethargy also started next day 05Dec2021, but continued through late afternoon 2 days following vaccination 06Dec2021. Reporter was not surprised by either of these symptoms as they are pretty common, but the second day after vaccination 06Dec2021, patient woke complaining of severe stomach pain, which was followed by vomiting (around 7:30 AM), constant nausea, and repeated bouts of vomiting, about once every 45 minutes, until about 1:00 PM when both vomiting and nausea stopped. The patient did not test for covid post vaccination. No relevant tests. The reporter consider the Pfizer product had a causal effect to the adverse events. The reporter considered the events lethargy, pyrexia, nausea, vomiting as non-serious.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and a plausible temporal association, the causa association between the event severe stomach pain and the suspect drug BNT162B2 cannot be totally excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.