Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prevention. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ALKS 4230 for Neoplasm and PEMBROLIZUMAB (KEYTRUDA) for Neoplasm.    The patient's past medical history included Nausea (With previous chemotherapy or event before on current treatment), Vomiting (With previous chemotherapy or event before on current treatment) and Chemotherapy (Nausea/vomiting with previous chemotherapy.). Previously administered products included for Metastatic malignant melanoma: Pegylated Interferon from September 2012 to 07-Jun-2017, Nivolumab from 21-Jul-2017 to 28-Sep-2017, Ipilimumab from 21-Jul-2017 to 28-Sep-2017, Cisplatin from 27-Jun-2020 to 09-Sep-2020, Dacarbazine from 27-Jun-2020 to 09-Sep-2020 and Carmustine on 17-Aug-2020. Past adverse reactions to the above products included No adverse event with Carmustine, Cisplatin, Dacarbazine, Ipilimumab, Nivolumab and Pegylated Interferon. Concurrent medical conditions included Neoplasm and Metastatic malignant melanoma (Stage four.) since 2012.   On 02-Nov-2020, the patient started ALKS 4230 (Intravenous) 3 mcg every three weeks. On 08-Feb-2021, the patient started PEMBROLIZUMAB (KEYTRUDA) (Intravenous) 200 milligram every three weeks. On 30-Aug-2021, PEMBROLIZUMAB (KEYTRUDA) (unknown route) dosage was changed to Unknown. On 03-Sep-2021, ALKS 4230 (unknown route) dosage was changed to Unknown. On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criteria hospitalization prolonged and medically significant) and VOMITING (Vomiting) (seriousness criteria hospitalization prolonged and medically significant). On 13-Sep-2021, the patient experienced PYREXIA (Fever). The patient was hospitalized until 15-Sep-2021 due to NAUSEA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of Unknown; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) at a dose of Unknown and KETOROLAC TROMETHAMINE (TORADOL) at a dose of Unknown. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, Body temperature: 37.9 (High) body temperature was high (37.9 degree Celsius).         The patients race unknown. The patient was admitted to hospital with plans to receive fluids, IV anti-nausea medication and for observation. Treatment with ALKS 4230 and Keytruda was reported as interrupted on 20 Sep 2021 due to the event of nausea and vomiting. A restart date of 18 Oct 2021 was reported for ALKS 4230 and Keytruda. On 13 Sep 2021 the subject received treatment with an IV bolus infusion of 0.9% sodium chloride. On 14 Sep 2021 the subject received another IV bolus infusion of 0.9% sodium chloride and then the treatment with sodium chloride was stopped. Company comment: This case concerns a 61-year-old, female patient with medical history of advanced metastatic melanoma and concurrent use of pembrolizumab, who experienced the unexpected events of nausea and vomiting which required hospitalization. The events occurred on the same day after the third dose of mRNA-1273. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The above mentioned medical history and concurrent use of pembrolizumab remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, female patient with medical history of advanced metastatic melanoma and concurrent use of pembrolizumab, who experienced the unexpected events of nausea and vomiting which required hospitalization. The events occurred on the same day after the third dose of mRNA-1273. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The above mentioned medical history and concurrent use of pembrolizumab remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.