Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia, Interchange of vaccine products, Malaise, Nausea, Pyrexia
Clinical narrative: Interchange of vaccine product; Severe abdominal cramping/most severe that he had in his entire life/his pain was a 10 out of 10 but today it is a 1 out of 10/localized pain on right side abdominal region; 102 degrees F fever; Nausea; Vomiting; Arthralgia; slept for about 36 hours; Malaise; zero appetite; Dry heaving; confusion; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSOMNIA (slept for about 36 hours), MALAISE (Malaise), DECREASED APPETITE (zero appetite), RETCHING (Dry heaving) and CONFUSIONAL STATE (confusion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Batch number: EH9899) on 08-Dec-2020, Pfizer COVID-19 vaccine (Batch number: EL1284) on 08-Jan-2021 and Pfizer COVID-19 vaccine (Batch number: FF8841) on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine, Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine. Concomitant products included LISINOPRIL for an unknown indication.    On 22-Jun-2022 at 3:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced HYPERSOMNIA (slept for about 36 hours), MALAISE (Malaise), DECREASED APPETITE (zero appetite), RETCHING (Dry heaving), CONFUSIONAL STATE (confusion), PYREXIA (102 degrees F fever), NAUSEA (Nausea), VOMITING (Vomiting) and ARTHRALGIA (Arthralgia). On 24-Jun-2022 at 3:00 AM, the patient experienced ABDOMINAL PAIN (Severe abdominal cramping/most severe that he had in his entire life/his pain was a 10 out of 10 but today it is a 1 out of 10/localized pain on right side abdominal region). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (slept for about 36 hours), MALAISE (Malaise), DECREASED APPETITE (zero appetite), RETCHING (Dry heaving), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN (Severe abdominal cramping/most severe that he had in his entire life/his pain was a 10 out of 10 but today it is a 1 out of 10/localized pain on right side abdominal region), PYREXIA (102 degrees F fever), NAUSEA (Nausea), VOMITING (Vomiting) and ARTHRALGIA (Arthralgia) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 102 degrees F fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Moderna first booster on the right side as well.  Patient usually drinks a glass of wine with his dinner but he has not had a drop of alcohol since 23-Jun-2022 which was unusual for him. On 26-Jun-2022, he started feeling better. He was still experiencing these mildly. On 24-jun-2022, his pain was a 10 out of 10 but on 28-Jun-2022,it was 1 out of 10. This was localized pain on right side abdominal region.  Company comment: This spontaneous case concerns a 60-year-old male patient, with no reported medical history, who experienced the unexpected non-serious AESI Hypersomnia that occurred on an unspecified date after receiving the mRNA-1273 vaccine as 4th dose. Patient had 102 degrees fever, nausea, vomiting, dry heaving, malaise, arthralgia, confusion, zero appetite and slept for about 36 hours. Patient received 3 doses of Tozinameran vaccine with no reported adverse events, with the 3rd dose given 7 months and 28 days prior to the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 60-year-old male patient, with no reported medical history, who experienced the unexpected non-serious AESI Hypersomnia that occurred on an unspecified date after receiving the mRNA-1273 vaccine as 4th dose. Patient had 102 degrees fever, nausea, vomiting, dry heaving, malaise, arthralgia, confusion, zero appetite and slept for about 36 hours. Patient received 3 doses of Tozinameran vaccine with no reported adverse events, with the 3rd dose given 7 months and 28 days prior to the mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement.