Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia, Somnolence
Clinical narrative: Slept for a long time and after she woke up she went back to bed like she wants to go back to sleep; She had a really small appetite; Very abnormal for her to be so tired and sleepy; Complained of some chest pain on the sides of her chest; Within 10 hours of receiving the vaccine, she started experiencing a high fever of 102.7F; Really tired; 1st dose administered on 29JUN2022  and 2nd dose administered on 4AUG2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERSOMNIA (Slept for a long time and after she woke up she went back to bed like she wants to go back to sleep), DECREASED APPETITE (She had a really small appetite), SOMNOLENCE (Very abnormal for her to be so tired and sleepy), CHEST PAIN (Complained of some chest pain on the sides of her chest) and PYREXIA (Within 10 hours of receiving the vaccine, she started experiencing a high fever of 102.7F) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: IPV vaccine (IPV vaccine) on 22-Jul-2022, HEPB Vaccine (HEPB Vaccine) on 22-Jul-2022 and PCV13 Vaccine (PCV13 Vaccine) on 22-Jul-2022. Past adverse reactions to the above products included No adverse event with HEPB Vaccine, IPV vaccine and PCV13 Vaccine.   On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2022, the patient experienced HYPERSOMNIA (Slept for a long time and after she woke up she went back to bed like she wants to go back to sleep), DECREASED APPETITE (She had a really small appetite), SOMNOLENCE (Very abnormal for her to be so tired and sleepy), CHEST PAIN (Complained of some chest pain on the sides of her chest), PYREXIA (Within 10 hours of receiving the vaccine, she started experiencing a high fever of 102.7F), FATIGUE (Really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 29JUN2022  and 2nd dose administered on 4AUG2022). On 05-Aug-2022, CHEST PAIN (Complained of some chest pain on the sides of her chest) and PYREXIA (Within 10 hours of receiving the vaccine, she started experiencing a high fever of 102.7F) had resolved. At the time of the report, HYPERSOMNIA (Slept for a long time and after she woke up she went back to bed like she wants to go back to sleep), DECREASED APPETITE (She had a really small appetite), SOMNOLENCE (Very abnormal for her to be so tired and sleepy) and FATIGUE (Really tired) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 29JUN2022  and 2nd dose administered on 4AUG2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2022, Body temperature: 102.7 102.7 F.         Patient had no reported allergies. Patient never had COVID-19 test or diagnosis. AE did not caused patient to seek medical care. Patient had not experienced a similar event in the past. Patient had no history of Myocarditis/pericarditis.  No concomitant medication was reported. No treatment details were reported.  Company comment: This spontaneous case concerns a 3-year-old, female patient with past drug history of administration of the Inactivated Poliovirus vaccine (IPV), Pneumococcal 13-valent conjugate vaccine (PCV13) and Hepatitis B vaccine 13 days before receiving the second dose of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of hypersomnia, and other unexpected and expected, non-serious events. The event pyrexia occurred within 10 hours after receiving the second dose of the mRNA-1273 vaccine. The other events occurred on the same day after receiving the second dose of the mRNA-1273 vaccine. Of note, the second dose was given 36 days after the first dose of the mRNA-1273 vaccine (inappropriate schedule of product administration). It was reported that within 10 hours of receiving the vaccine, the patient started experiencing a high fever (102.7 F). It was also reported that the patient was really tired and slept for a long time. After she woke up, she had a really small appetite and went back to bed like she wanted to go back to sleep. The reporter also stated that the patient complained of some 'chest pain' on the sides of her chest. No treatment was reported. However, the events pyrexia and chest pain had resolved 1 day after vaccination. The other events had not resolved at the time of the report. The history of administration of IPV remains a confounder for the events pyrexia and fatigue which are common adverse effects of the vaccine. The history of administration of the Hepatitis B vaccine remains a confounder for the event pyrexia which is a common adverse effect of the vaccine. The history of administration of PCV13 remains a confounder for the events decreased appetite and fatigue which are common adverse effects of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2022-623954 (Patient Link).; Sender's Comments: This spontaneous case concerns a 3-year-old, female patient with past drug history of administration of the Inactivated Poliovirus vaccine (IPV), Pneumococcal 13-valent conjugate vaccine (PCV13) and Hepatitis B vaccine 13 days before receiving the second dose of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of hypersomnia, and other unexpected and expected, non-serious events. The event pyrexia occurred within 10 hours after receiving the second dose of the mRNA-1273 vaccine. The other events occurred on the same day after receiving the second dose of the mRNA-1273 vaccine. Of note, the second dose was given 36 days after the first dose of the mRNA-1273 vaccine (inappropriate schedule of product administration). It was reported that within 10 hours of receiving the vaccine, the patient started experiencing a high fever (102.7 F). It was also reported that the patient was really tired and slept for a long time. After she woke up, she had a really small appetite and went back to bed like she wanted to go back to sleep. The reporter also stated that the patient complained of some 'chest pain' on the sides of her chest. No treatment was reported. However, the events pyrexia and chest pain had resolved 1 day after vaccination. The other events had not resolved at the time of the report. The history of administration of IPV remains a confounder for the events pyrexia and fatigue which are common adverse effects of the vaccine. The history of administration of the Hepatitis B vaccine remains a confounder for the event pyrexia which is a common adverse effect of the vaccine. The history of administration of PCV13 remains a confounder for the events decreased appetite and fatigue which are common adverse effects of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.