Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue, Pyrexia
Clinical narrative: have a temperature of 101.3 F; Patients received Moderna COVID-19 Vaccine after temperature excursions; Patients received Moderna COVID-19 Vaccine after temperature excursions; There was a report of seizure-like activity/Turned his head to the right and his body tensed up, he then leaned right and began drooling/diagnosed with epilepsy; Patients received Moderna COVID-19 Vaccine after temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EPILEPSY (There was a report of seizure-like activity/Turned his head to the right and his body tensed up, he then leaned right and began drooling/diagnosed with epilepsy) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 013F21A, 032M20A and 010M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy.   On 10-Feb-2021 at 12:31 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Mar-2021 at 12:52 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 23-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-May-2022 at 12:26 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 05-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna COVID-19 Vaccine after temperature excursions). On 06-May-2022, the patient experienced EPILEPSY (There was a report of seizure-like activity/Turned his head to the right and his body tensed up, he then leaned right and began drooling/diagnosed with epilepsy) (seriousness criterion medically significant) and POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna COVID-19 Vaccine after temperature excursions). On an unknown date, the patient experienced PYREXIA (have a temperature of 101.3 F) and PRODUCT STORAGE ERROR (Patients received Moderna COVID-19 Vaccine after temperature excursions). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 650 milligram. On 06-May-2022, EPILEPSY (There was a report of seizure-like activity/Turned his head to the right and his body tensed up, he then leaned right and began drooling/diagnosed with epilepsy) had resolved. On 24-May-2022, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna COVID-19 Vaccine after temperature excursions) had resolved. At the time of the report, PYREXIA (have a temperature of 101.3 F), PRODUCT STORAGE ERROR (Patients received Moderna COVID-19 Vaccine after temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna COVID-19 Vaccine after temperature excursions) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2022, Body temperature: 98.2 98.2 at 2:47 am. On an unknown date, Body temperature: 101.3 101.3 F. On an unknown date, Heart rate: regular Regular.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EPILEPSY (There was a report of seizure-like activity/Turned his head to the right and his body tensed up, he then leaned right and began drooling/diagnosed with epilepsy) to have an unknown relationship. No further causality assessments were provided for PYREXIA (have a temperature of 101.3 F), PRODUCT STORAGE ERROR (Patients received Moderna COVID-19 Vaccine after temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Patients received Moderna COVID-19 Vaccine after temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna COVID-19 Vaccine after temperature excursions).    No concomitant medication was provided by reporter.  Patient received Moderna COVID-19 vaccine (2nd booster) on 06-May-2022 at 12:26 pm. At 4:48 pm that same day, direct care staff reported that while seated at a table, patient turned his head to the right and his body tensed up. He then leaned right and began drooling. At 4:52 pm there was a report of seizure-like activity (head turning and drooling with clenching of the body) occurring for about 45 seconds. Following the episode, patient perked up and began moving normally after approximately 3 minutes. Vital signs were then obtained showing a regular heart rate. Patient was diagnosed with epilepsy. Patient then returned to his home for 24 hour seizure monitoring and was noted initially to have a temperature of 101.3 F for which he was given acetaminophen 650mg. His follow up temperature at 2:47am on 07-May-2022 was 98.2   Company comment: This is an spontaneous case concerning a 31-years-old male patient with  medical history of epilepsy who experienced the unexpected events of epilepsy (seriousness criterion medically significant), product temperature excursion issue, poor quality product administrated, product storage error and other expected event the same day of the  4th. dose of  mRNA-1273 vaccine.  The medical history of epilepsy as a contributing factor for this event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2022: Significant follow up received which included patient demographics (Patient age, gender, height and initial). Dosage regimens added for Moderna vaccine, treatment medication added, event epilepsy was added.; Sender's Comments: This is an spontaneous case concerning a 31-years-old male patient with  medical history of epilepsy who experienced the unexpected events of epilepsy (seriousness criterion medically significant), product temperature excursion issue, poor quality product administrated, product storage error and other expected event the same day of the  4th. dose of  mRNA-1273 vaccine.  The medical history of epilepsy as a contributing factor for this event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.