Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pyrexia, Vomiting
Clinical narrative: vomiting; high fever/T-Max was 103.5; Rigors/chills; Body aches; allergy/would just refer the patient to an allergist; received 3 Moderna vaccines in 2022 and one Pfizer vaccine 2023; received 3 Moderna vaccines in 2022 and one Pfizer vaccine 2023; diarrhea; This is a spontaneous report received from a Physician from medical information team.  A 4-year-old female patient received BNT162b2 omi xbb.1.5 (PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA)), in 2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE, Manufacturer: Moderna), administration date: 2022, for Covid-19 Immunization, reaction(s): "Low grade fever", "pain injection site"; Moderna (DOSE 2, SINGLE, Manufacturer: Moderna), administration date: 2022, for Covid-19 Immunization, reaction(s): "Low grade fever", "pain injection site"; Moderna (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Moderna), administration date: 2022, for Covid-19 Immunization, reaction(s): "Low grade fever", "pain injection site". The following information was reported: PAIN (non-serious) with onset 2023, outcome "recovered" (2023), described as "Body aches"; CHILLS (non-serious) with onset 2023, outcome "recovered" (2023), described as "Rigors/chills"; ALLERGY TO VACCINE (non-serious) with onset 2023, outcome "recovered" (2023), described as "allergy/would just refer the patient to an allergist"; PYREXIA (non-serious) with onset 2023, outcome "recovered" (2023), described as "high fever/T-Max was 103.5"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 2023, outcome "unknown" and all described as "received 3 Moderna vaccines in 2022 and one Pfizer vaccine 2023"; VOMITING (medically significant) with onset 2023, outcome "recovered" (2023); DIARRHOEA (non-serious), outcome "recovered" (2023), described as "diarrhea". The patient underwent the following laboratory tests and procedures: Body temperature: 103.5. Therapeutic measures were taken as a result of pyrexia.  Clinical course: The reporter called about Pfizer BioNTech COVID-19 vaccines for 6 months through 5 years. She reported that she had a 'little gal' who received 3 Moderna vaccines in 2022 and one Pfizer vaccine 2023 and had "progressively worsening side effects". The patient has not had any in 2024.  The patient would have been 4 last year.  She explained from the first vaccine patient received, the patient experienced low grade fever and pain at the injection site. The patient's side effects seem to get worse every time she gets the vaccine. When she got the Pfizer Covid 19 Vaccine 6 months to 5 years, within 8 hours, the patient had a high fever with body aches and rigor/chills. The T-Max was 103.5. She also had vomiting and diarrhea. She confirmed events have ended, patient is fine now. This was a year ago (2023). These events all ended within approximately 24 hours. She wanted to know if other medical providers have an insight whether should the patient still receive another dose or if this is a side effect or an allergy. She mentioned that she realized that there's really no way to determine if the patient is having a reaction to a component of the vaccine or just an immune response and she thinks that the best action is for the patient to be checked by a specialist. She said would just refer the patient to an allergist. She also wanted to know if there is any guidance going forward in getting the older vaccine, Covid 19 Vaccine 5-11 year old.  Treatment for the high fever included Tylenol and Ibuprofen, the patient responded to medication. The reporter assessed the event vomiting as medically significant as this was unusual.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event vomiting and the suspect drug BNT162B2 OMI XBB.1.5. 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.