Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Pyrexia
Clinical narrative: fever of 101-102 degrees Fahrenheit; severe stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2022 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 5 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PYREXIA (medically significant) with onset 05Jun2022 at 01:00, outcome "recovered" (05Jun2022), described as "fever of 101-102 degrees Fahrenheit"; ABDOMINAL PAIN UPPER (non-serious) with onset 05Jun2022 at 01:00, outcome "recovered" (05Jun2022 at 04:00), described as "severe stomach pain". The patient underwent the following laboratory tests and procedures: Body temperature: (05Jun2022) 101-102 Fahrenheit, notes: fever of 101-102 degrees Fahrenheit; (05Jun2022) 99 Fahrenheit, notes: It reduced to around 99 degrees Fahrenheit. Therapeutic measures were not taken as a result of pyrexia, abdominal pain upper.  Clinical information: Pharmaceutical form (dosage form): Injection. Consumer reporter was patient's mother. HCP Type: Paediatrician. Reason for no lot number: of Covid-19 vaccine booster: Complainant does not have the product with them at the time of call. Expiry Date of Covid-19 vaccine booster was unknown. Covid-19 vaccine booster: dosage change not provided. Other Products: No. Consumer calling regarding the COVID vaccine for 5 and up, specifically the booster. She was calling to report that her daughter experienced side effects to the booster she received at 9:00 AM on Saturday. Around 1:00 AM at night her daughter experienced severe stomach pain and a fever of 101-102 degrees Fahrenheit. Patient age of AE onset: 5 years and 8 months. HCP details: She was n't the physician that was there at the time, but she is her paediatrician. Severe stomach pain: lasted 3 hours. Fever of 101-102 degrees Fahrenheit: started at the same time as the stomach pain. The fever ended Sunday morning. It reduced to around 99 degrees Fahrenheit. Treatment: She called withheld , they have an on call adviser, to see if she should give medication for the severe stomach pain and fever. The agent advised her not give anything until 24 hours later from getting the booster. Caller was not sure if that was correct. Until 9:00 AM the next morning, which was 24 hours after booster was received, she did not give anything because her daughter was getting better. Caller asked if this was correct: Her daughter received the booster 9:00 AM, 04Jun2022, Saturday morning. She did not have the vaccination card. It was in the system at the doctor's office. She did not know the NDC/LOT/Expiry because she did not bring the card into the doctor's office. It was in their system at HCP office. Dose number was unknown. Indication: It's her booster and they wanted their daughter to get up to date on that. Caller asked was there a nasal spray. What is safe to take regarding an experience related to the vaccine. Her son was under 5 and when he takes it and if he had an adverse event, she would like to call someone to see what is appropriate to take. Caller declines Vaccine Supplemental Form.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.