Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: extreme vomiting and diarrhea; Mild fever; extreme vomiting and diarrhea; This is a spontaneous report received from contactable reporter (Pharmacist) from medical information team.  A 7-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 3 (orange cap; booster), 0.2 ml single (Batch/Lot number: unknown) at the age of 7 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, he got the first two shots of the primary series last year), administration date: 2021, for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, he got the first two shots of the primary series last year), administration date: 2021, for Covid-19 immunization. The following information was reported: VOMITING (medically significant) with onset 03Nov2022, outcome "recovering", DIARRHOEA (medically significant) with onset 04Nov2022 at 02:00, outcome "recovering" and all described as "extreme vomiting and diarrhea"; PYREXIA (medically significant) with onset 04Nov2022, outcome "recovering", described as "Mild fever". The events "extreme vomiting and diarrhea" and "mild fever" required physician office visit. Therapeutic measures were taken as a result of vomiting, pyrexia. Therapeutic measures were not taken as a result of diarrhoea. The pharmacist reported that the patient received the COVID-19 vaccine orange cap bivalent booster and, 5 hours later, he developed extreme vomiting and diarrhea. The reporter also stated that he also had a mild fever. He had severe vomiting, diarrhea and early this morning started experiencing a mild fever. It was mentioned that he got the first two shots of the primary series last year. The pharmacist called to see if vomiting happened before to previous patients. The reporter wanted to make sure that going to the doctor and getting treatment was the right thing to do. Vomiting was getting a little bit better but was still vomiting. The patient is seeing a pediatrician in the morning as soon as the office opens at 9 for medical attention. They gave him pedialyte. For the mild fever, he had Tylenol so that it would not increase and to keep the fever controlled. For diarrhea, it started on 04Nov2022 02:00, no treatment. The pharmacist assessed the events as serious (medically significant).    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as 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.