Age: 4.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Body temperature, Headache, Off label use, Pain
Clinical narrative: peribronchial cuffing; has a low grade fever; Cough; he woke up crying with a headache; he woke up crying with a headache; right arm hurts; patient received a full adult dose; 4-year-old male grandchild accidentally received Pfizer COVID vaccine first dose; accidentally received Pfizer COVID vaccine first dose instead of flu vaccine; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 26Oct2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report from a contactable consumer (patients's grandmother) and physician via medical information team. This is the first of 2 reports. A 4-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in Arm Right, at age 4 years, on 04Oct2021 16:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization; and influenza vaccine (FLU VACCINE, unspecified), via an unspecified route of administration from 04Oct2021 (Batch/Lot number was not reported) to 04Oct2021, at DOSE NUMBER UNKNOWN, SINGLE for immunisation. Relevant medical history includes ADHD but patient have not been diagnosed with that. There were no concomitant medications. The patient historically received flu vaccine every year for immunization and was whiny or feeling bad after. The patient's grandmother reported that the 4-year-old male grandchild accidentally received Pfizer COVID vaccine first dose instead of flu vaccine on  04Oct2021 around 4pm at redacted. On the night of 04Oct2021, the patient went for flu vaccines and received the Pfizer COVID 19 vaccine instead. The patient received a full adult dose. Card was not given because the pharmacy believed the flu vaccine had been given not the COVID-19 vaccine. The pharmacy called about an hour and a half after the vaccines were given to let the mother know a mistake had been made. The reporter was reaching out to Pfizer because poison control, the pediatrician, and the emergency department didn't know what to do. The reporter was advised to just keep an eye on the children. On 05Oct2021, patient experienced a low grade fever and he woke up crying with a headache. Tylenol helps with his fever. Patient had a fever an hour after receiving the vaccine. The patient also experienced sore arm/right arm hurts and cough on 05Oct2021. The reporter stated that the patient's mother has been keeping the patient pumped full of Tylenol. Giving the children Tylenol was the only suggestion that was given when calling for advice last night. Instead of waiting for the fever to spike, she is staying on top of it by giving the Tylenol. Vaccination Facility Type was at a pharmacy or drug store, not at a facility. Fever and cough required physicain's office visit and treatment required. The patient underwent lab tests and procedures that includes Troponin-T on 07Oct2021 with result of less than 6, then on 12Oct2021 with result of 10; Chest X-Ray on 08Oct2021 with result peribronchial cuffing; EKG and echocardiogram on 07Oct2021 were normal. As per reporting physician, the patient provided information regarding the reported adverse events with the use of the product and considers the Pfizer product had a causal effect to the adverse event. The outcome of the event low grade fever and cough was recovering; while for the other events, it was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to the events low grade fever and cough cannot be excluded based on temporal relationship, lack of reported alternative explanation at this time and since it is part of the product safety profile. 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.,Linked Report(s) : US-PFIZER INC-202101316959 same reporter/drug, similar events, different patients