Age: 61.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Body temperature, Nausea, Vomiting
Clinical narrative: vomiting; nausea; This spontaneous case was reported by an other and describes the occurrence of VOMITING (vomiting) and NAUSEA (nausea) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products  for Neoplasm and PEMBROLIZUMAB (KEYTRUDA) for Neoplasm.    The patient's past medical history included Nausea (With previous chemotherapy or ever before on current treatment) and Vomiting (With previous chemotherapy or ever before on current treatment). Previously administered products included for Metastatic malignant melanoma: Pegylated interferon alfa 2A (Stage IV) from September 2012 to 07-Jun-2017, Nivolumab (Stage IV) from 21-Jul-2017 to 28-Sep-2017, Ipilimumab (Stage IV) on 21-Jul-2017, Dacarbazine (Stage IV) from 27-Jun-2020 to 09-Sep-2020, Cisplatin (Stage IV) from 27-Jun-2020 to 09-Aug-2020 and carmustine (Stage IV) on 17-Aug-2020. Past adverse reactions to the above products included No adverse event with Cisplatin, Dacarbazine, Ipilimumab, Nivolumab, Pegylated interferon alfa 2A and carmustine. Concurrent medical conditions included Metastatic malignant melanoma (Stage IV) since June 2012.   On 02-Nov-2020, the patient started non company product (Intravenous) 30 microgram/kilogram every three weeks. On 08-Feb-2021, the patient started PEMBROLIZUMAB (KEYTRUDA) (Intravenous) at an unspecified dose every three weeks. On 12-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, non company product (Intravenous) dosage was changed to 30 microgram/kilogram every three weeks and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) dosage was changed to at an unspecified dose every three weeks. On 12-Sep-2021, the patient experienced VOMITING (vomiting) (seriousness criteria hospitalization and medically significant) and NAUSEA (nausea) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-Sep-2021 to 15-Sep-2021 due to NAUSEA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. On 18-Oct-2021, VOMITING (vomiting) and NAUSEA (nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, Body temperature: 37.9 (High) 37.9 degree celsius max.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Subject received treatment with IV bolus infusion of 0.9% sodium chloride. No concomitant medications were reported. Company comment: This case concerns a 61-year-old, male patient, with medical history of metastatic malignant melanoma (stage IV) and on non company product and Pembrolizumab for neoplasm, who experienced the serious, unexpected events of nausea and vomiting. The events occurred  on the same day after booster dose of mRNA 1273 vaccine and lead to hospital admission where patient was treated with ondansetron, metoclopramide, ketorolac and IV bolus infusion of 0.9% sodium chloride. The reporter assessed the events as possibly related to the product. The patient's history of metastatic malignant melanoma and co-suspect drugs non company product and Pembrolizumab remain as confounders to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, male patient, with medical history of metastatic malignant melanoma (stage IV) and on noncompany product and Pembrolizumab for neoplasm, who experienced the serious, unexpected events of nausea and vomiting. The events occurred  on the same day after booster dose of mRNA 1273 vaccine and lead to hospital admission where patient was treated with ondansetron, metoclopramide, ketorolac and IV bolus infusion of 0.9% sodium chloride. The reporter assessed the events as possibly related to the product. The patient's history of metastatic malignant melanoma and co-suspect drugs non company product and Pembrolizumab remain as confounders to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.