Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: Red blood cell sedimentation rate, Syncope, Tremor, Tri-iodothyronine, Ultrasound scan
Clinical narrative: gastric mucosal irritation; He has syncope; Tremors; it could be post viral inflammation; difficulty in walking due to loss of sense of balance.; difficulty in walking due to loss of sense of balance.; he only has preserved mobility in bed; turn in decubitus position; dysphasia; He starts with constipation; Diagnosis of gastroenteritis; abdominal pain 9/10; Anorexia; Nausea; Feverish; Sax and flu.; Weight Loss: 5 kg in 10 days.; headache; weakness/weakness after taking BH; pharyngeal pain/pain throat; This spontaneous case was reported by an other health care professional and describes the occurrence of EPIGASTRIC DISCOMFORT (gastric mucosal irritation) and SYNCOPE (He has syncope) in a 12-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 9654271) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tiredness (March 20-25 Trip) in March 2023, Weight decreased (March 20-25 Trip) in March 2023, Abdominal pain (self-limited, March 20-25 Trip) in March 2023, Diarrhea (Apr 1-8 Trip) in April 2023, Flu (Apr 1-8 Trip) in April 2023, Cough (Apr 1-8 Trip) in April 2023, Mucus discharge (Apr 1-8 Trip) in April 2023, Fever (Apr 1-8 Trip) on 05-Apr-2023, Body temperature abnormal (Apr 1-8 Trip) on 05-Apr-2023 and Cold (cold: snot and throat.) on 05-Apr-2023. Previously administered products included for COVID-19 vaccination: Pfizer (Lot number: FKSTT20, Dose 1) on 14-Nov-2021, Pfizer (Lot number: FL0007 , Dose 2) on 30-Dec-2021, Pfizer (Lot number: H49991 and Dose 3 (booster)) on 16-Jul-2022; for Product used for unknown indication: Flu A and B (Flu A and B) in December 2022, Flu A and B (Flu A and B) in December 2022, Flu A and B (Flu A and B) in December 2022, FLU VACCINE VII (Flu A and B) in December 2022, Flu A and B (Flu A and B) in December 2022, Flu A and B (Flu A and B) in December 2022 and Flu Vaccine (October-November); for Drug use for unknown indication: Paracetamol (1 week) since an unknown date and Oseltamivir (1 week). Past adverse reactions to the above products included Abdominal pain with FLU VACCINE VII; Anorexia with Flu A and B; Fever with Flu A and B; Flu with Flu A and B; No adverse event with Flu Vaccine, Oseltamivir, Paracetamol, Pfizer, Pfizer and Pfizer; Tiredness with Flu A and B; and Weakness with Flu A and B.    On 09-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Apr-2023, the patient experienced INFLUENZA (Sax and flu.). On 12-Apr-2023, the patient experienced ABDOMINAL PAIN (abdominal pain 9/10), DECREASED APPETITE (Anorexia), NAUSEA (Nausea) and PYREXIA (Feverish). In April 2023, the patient experienced EPIGASTRIC DISCOMFORT (gastric mucosal irritation) (seriousness criterion hospitalization), ASTHENIA (weakness/weakness after taking BH), OROPHARYNGEAL PAIN (pharyngeal pain/pain throat), WEIGHT DECREASED (Weight Loss: 5 kg in 10 days.) and HEADACHE (headache). On 17-Apr-2023, the patient experienced GASTROENTERITIS (Diagnosis of gastroenteritis). On 23-Apr-2023, the patient experienced CONSTIPATION (He starts with constipation). On an unknown date, the patient experienced SYNCOPE (He has syncope) (seriousness criterion medically significant), TREMOR (Tremors), INFLAMMATION (it could be post viral inflammation), BALANCE DISORDER (difficulty in walking due to loss of sense of balance.), GAIT DISTURBANCE (difficulty in walking due to loss of sense of balance.), MOBILITY DECREASED (he only has preserved mobility in bed), DECUBITUS ULCER (turn in decubitus position) and APHASIA (dysphasia). The patient was hospitalized from sometime in April 2023 to sometime in April 2023 due to EPIGASTRIC DISCOMFORT. The patient was treated with HYOSCINE BUTYLBROMIDE (BUSCOPAN) on 13-Apr-2023 at an unspecified dose and frequency; HYOSCINE BUTYLBROMIDE (BUSCOPAN) in April 2023 at a dose of UNK, q8h; PARACETAMOL on 13-Apr-2023 at an unspecified dose and frequency; ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) in April 2023 at a dose of 40 milligram every twelve hours; PROBIOTICS NOS in April 2021 at a dose of probiolog GG sachets every 12 Hrs for 21 days; ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) in April 2023 at a dose of 6 oz every 3 hours for 24 hours; IBUPROFEN on 25-Apr-2023 at a dose of UNK, q6h and MACROGOL (CONTUMAX [MACROGOL]) on 26-Apr-2023 at an unspecified dose and frequency. At the time of the report, EPIGASTRIC DISCOMFORT (gastric mucosal irritation), SYNCOPE (He has syncope), ASTHENIA (weakness/weakness after taking BH), OROPHARYNGEAL PAIN (pharyngeal pain/pain throat), INFLUENZA (Sax and flu.), ABDOMINAL PAIN (abdominal pain 9/10), DECREASED APPETITE (Anorexia), TREMOR (Tremors), GASTROENTERITIS (Diagnosis of gastroenteritis), CONSTIPATION (He starts with constipation), INFLAMMATION (it could be post viral inflammation), BALANCE DISORDER (difficulty in walking due to loss of sense of balance.), WEIGHT DECREASED (Weight Loss: 5 kg in 10 days.), GAIT DISTURBANCE (difficulty in walking due to loss of sense of balance.), MOBILITY DECREASED (he only has preserved mobility in bed), DECUBITUS ULCER (turn in decubitus position), APHASIA (dysphasia), HEADACHE (headache), NAUSEA (Nausea) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2023, Ultrasound scan: no appendix found. In April 2023, Endoscopy: leaving with signs of gastric mucosal irritation. On 16-Apr-2023, Blood test: Normal. On 16-Apr-2023, Investigation: Coprology- Normal. On 21-Apr-2023, Blood creatine phosphokinase: 38 IU/L. On 21-Apr-2023, Blood ethanol: 5.86 m/'uL. On 21-Apr-2023, Blood glucose: 103 mg/dl. On 21-Apr-2023, Blood triglycerides: 166 mg/dl. On 21-Apr-2023, C-reactive protein: 0.29 ng/mL. On 21-Apr-2023, Haemoglobin: 15.5 g/dL. On 21-Apr-2023, Investigation: Chemistry: Serum mg 2 mg/dL, the other parameters are normal. and 46.4 %. On 21-Apr-2023, Red blood cell sedimentation rate: 12 mm/hr. On 21-Apr-2023, Tri-iodothyronine: 0.88 ng/mL. On 22-Apr-2023, Electromyogram: Normal, without signs of neuropathy and/or lumbar radiculopathy.. On 22-Apr-2023, Myocardial necrosis marker: Normal: Prone 27 mg. /mL, CKMB <1 ng/ml, Myoglob. 13.1 ng/ml, Tropon. I  ng/ml. April 23: Eco and Holter to rule outpost vaccine cardiopathy. On 22-Apr-2023, Nerve conduction studies: normal. On 23-Apr-2023, Electrocardiogram ambulatory: 24-hourrhythm analysis is performed,  100 percent heartbeat, sinus rhythm, PR 98-102 ms, QRS 78-82 ms, corrected QT within normal ranges, unrecorded ventricular ectopic activity, unrecorded ventricular ectopic activity, scant supraventricular ectopic activity (less than 1 percent), no episodes of supraventricular tachycardia, isolated heartbeats, a double, there are no clinically relevant breaks, the circadian index is 1.21, HRmax 147 bpm, HRmin: 47, average in day 75 bpm, at night 62 bpm. 6 percent of the total monitoring was sinus tachycardia and 0/0 sinus bradycardia (mainly nocturnal), no electrocardiographic abnormalities were observed.. On 29-Apr-2023, Magnetic resonance imaging: it came out normal (cross myelitis).  SIMPLE AND CONTRASTED CERVICAL SPINE MRI: No evidence of abnormal enhancements after  gadolinium administration. Rectification of cervical lordosis. Base of the skull without alteration; paravertebral and posterior cervical space without alterations; lymph nodes and vascular structures normal.. On 05-May-2023, Magnetic resonance imaging head: all normal. On an unknown date, Blood calcium: 10.3 mg/dl other parameters are normal. On an unknown date, Blood test: Hb 14.3, Hto. 42.8, all other data normal.. On an unknown date, Neurological examination: had preserved mobility in bed, slowly but manages to sit, turn in decubitus position, squat (on the bed) walk dysphasia with weakness and fatigue.. On an unknown date, Physical examination: Weight: 1.58  Height: 46.6. On an unknown date, Weight: Weight Loss: 5 kg in 10 days.. On an unknown date, pH urine: 8, Otherwise normal.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug information was not provided.  It was reported that the patient was a soccer player (played soccer 2 hrs a day for 5 days). Patient's mother had Hypothyroidism, however, patient himself negative personal non-pathological antecedents.  Patient went for a trip from 3-10 February and that was with out any eventuality.  After the Moderna bivalent vaccination, patient was prescribed with Pedialyte for 24 Hrs, however, the patient didn't complete the 24 Hrs and the clinical condition worsened (more weakness), they took him to gastroenterologist who prescribed them to start a diet. Patient was given chicken and vegetables as prescribed by Gastrology to increase the patient's condition. On April 19, Patient started with a strict diet where he was fed every 2 hours: vegetables, fruits, and meats. On April 19-21, patient had weakness, ate well and was antibiotic free. On 23Apr2023, ECO was performed, and everything was normal.  At the time of report, Gastritis was being treated with an improvement in abdominal condition however, patient persisted with dizziness, weakness and difficulty in walking due to loss of sense of balance.  On 5May2023, patient was prescribed a lumbar puncture.  Company Comment: This is a spontaneous case concerning a 12-year-old male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of syncope and the unexpected serious (hospitalization) event of epigastric discomfort among other non-serious events. The events occurred on unknown day after a dose of mRNA-1273.222 vaccine, received as the fourth dose for COVID-19 Vaccination. Primary vaccination was with Pfizer vaccine. Patient was admitted to the hospital for further investigation. He had blood test done, coprology with normal result, endoscopy with signs of gastric mucosal irritation. He has been reviewed by neurologist and electromyogram, magnetic resonance imaging of head and body were performed  all normal. Holter ECG and myocardial markers were also normal. Patient was treated with Buscopan, Nexium, Probiotics, Paracetamol with good effect. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-725236, MX-MODERNATX, INC.-MOD-2023-725238 (Linked Report).; Reporter's Comments: This is a spontaneous case concerning a 12-year-old male patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of syncope and the unexpected serious (hospitalization) event of epigastric discomfort among other non-serious events. The events occurred on unknown day after a dose of mRNA-1273.222 vaccine, received as the fourth dose for COVID-19 Vaccination. Primary vaccination was with Pfizer vaccine. Patient was admitted to the hospital for further investigation. He had blood test done, coprology with normal result, endoscopy with signs of gastric mucosal irritation. He has been reviewed by neurologist and electromyogram, magnetic resonance imaging of head and body were performed  all normal. Holter ECG and myocardial markers were also normal. Patient was treated with Buscopan, Nexium, Probiotics, Paracetamol with good effect. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725236:Mother case MX-MODERNATX, INC.-MOD-2023-725238:Patient case (Agency)