Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Oropharyngeal pain, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: sneezing; runny nose; developed an extreme sore throat that lasted 30 hours/sore throat came back; too tired; EKG borderline QT prolongation; heartburn after eating a biscuit; chest hurt; felt very cold; lightheaded; sore right knee; did not feel good; slight fever; Give Moderna vaccine at 13 years of agee; This spontaneous case was reported by a consumer and describes the occurrence of ELECTROCARDIOGRAM QT PROLONGED (EKG borderline QT prolongation) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Asthma.    On 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give Moderna vaccine at 13 years of agee). On 28-Aug-2021, the patient experienced FEELING ABNORMAL (did not feel good), ARTHRALGIA (sore right knee) and PYREXIA (slight fever). On 30-Aug-2021, the patient experienced ELECTROCARDIOGRAM QT PROLONGED (EKG borderline QT prolongation) (seriousness criterion medically significant), BURNING SENSATION (heartburn after eating a biscuit), CHEST PAIN (chest hurt), FEELING COLD (felt very cold), DIZZINESS (lightheaded) and FATIGUE (too tired). On 01-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (developed an extreme sore throat that lasted 30 hours/sore throat came back). On 09-Sep-2021, the patient experienced SNEEZING (sneezing) and RHINORRHOEA (runny nose). On 30-Aug-2021, FEELING ABNORMAL (did not feel good), ARTHRALGIA (sore right knee) and PYREXIA (slight fever) had resolved. On 13-Sep-2021, OROPHARYNGEAL PAIN (developed an extreme sore throat that lasted 30 hours/sore throat came back), SNEEZING (sneezing) and RHINORRHOEA (runny nose) had resolved. At the time of the report, ELECTROCARDIOGRAM QT PROLONGED (EKG borderline QT prolongation) outcome was unknown, BURNING SENSATION (heartburn after eating a biscuit), CHEST PAIN (chest hurt), FEELING COLD (felt very cold), DIZZINESS (lightheaded) and FATIGUE (too tired) was resolving and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give Moderna vaccine at 13 years of agee) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Positive. On 30-Aug-2021, C-reactive protein: 20.2 (High) should be under 8..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.  The reporter stated that patient was given Moderna vaccine instead of the Pfizer vaccine and noticed it after injection when they handed their vaccination card It was on 27August 2021 in right arm and patient had been exposed to Covid-19 in November of 2020 and was positive for it. On 28Aug2021 patient woke up and said right knee was hurting and patient did not feel good all weekend and had a small fever. On 30August 2021 patient had heartburn after eating a biscuit at school and said chest hurt, patient used asthma inhaler twice instead of once and became lightheaded and felt very cold.  Patient was too tired to go in the house when they got home and took him to the doctor that afternoon and they did bloodwork and then went to a hospital for an EKG. The results of the bloodwork were a CRP of 20.2 which should be under 8 and they wanted to repeat the bloodwork on 1 September 2021 and patient developed an extreme sore throat that lasted 30 hours and then his asthma started acting up. On 9 September 2021 the sore throat came back, sneezing, and very runny nose these lasted until 13 September 2021, Patient is now started feeling better.  Company Comment: This is a case of 'Product administered to patient of inappropriate age' for this 13-year-old, male with a medical history of asthma, who experienced the unexpected serious event of ECG QT prolonged; unexpected non-serious events of feeling abnormal, chest pain, feeling cold, oropharyngeal pain, sneezing, rhinorrhea and dizziness; expected non-serious events of pyrexia arthralgia and fatigue. The events occurred 3 days after receiving Moderna mRNA-1273 Vaccine (dose number unknown). The rechallenge is not applicable as the events were reported after a single dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a case of 'Product administered to patient of inappropriate age' for this 13-year-old, male with a medical history of asthma, who experienced the unexpected serious event of ECG QT prolonged; unexpected non-serious events of feeling abnormal, chest pain, feeling cold, oropharyngeal pain, sneezing, rhinorrhea and dizziness; expected non-serious events of pyrexia arthralgia and fatigue. The events occurred 3 days after receiving Moderna mRNA-1273 Vaccine (dose number unknown). The rechallenge is not applicable as the events were reported after a single dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. (Further information is requested).