Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; fever; This spontaneous case was reported by an other health care professional 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 COVID-19 vaccination and Prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products ALKS 4230 injection for Neoplasm and PEMBROLIZUMAB (KEYTRUDA) injection for Neoplasm.    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) from 21-Jul-2017 to 28-Sep-2017, CISPLATIN (Stage IV) from 27-Jun-2020 to 09-Sep-2020, DACARBAZINE (Stage IV) from 27-Jun-2020 to 09-Sep-2020 and CARMUSTINE (Stage IV) on 17-Aug-2020. Past adverse reactions to the above products included No adverse event with CARMUSTINE, CISPLATIN, DACARBAZINE, IPILIMUMAB, Nivolumab and Pegylated interferon ALFA- 2A. Concurrent medical conditions included Neoplasm, Metastatic malignant melanoma (Stage IV) since June 2012, Nausea (with previous chemotherapy or even before on current treatment) and Vomiting (with previous chemotherapy or even before on current treatment).   On 02-Nov-2020, the patient ALKS 4230 (Intravenous) dosage was changed to 3 microgram/kilogram every three weeks. On 08-Feb-2021, PEMBROLIZUMAB (KEYTRUDA) (Intravenous) dosage was changed to 200 milligram every three weeks. On 12-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, ALKS 4230 (Intravenous) dosage was changed to 3 microgram/kilogram every three weeks and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) dosage was changed to 200 milligram every three weeks. On an unknown date, the patient started ALKS 4230 (Intravenous) 3 microgram/kilogram every three weeks and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) 200 milligram every three weeks. On 12-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criteria hospitalization and medically significant). 12-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criteria hospitalization and medically significant). On 13-Sep-2021, the patient experienced PYREXIA (fever). The patient was hospitalized on 13-Sep-2021 due to NAUSEA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea and Vomiting, at an unspecified dose and frequency; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Nausea and Vomiting, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Nausea and Vomiting, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved with sequelae 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) 37.9 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NAUSEA (Nausea) and VOMITING (Vomiting) to be possibly related. No further causality assessment was provided for PYREXIA (fever).    Concomitant product use was not provided by the reporter. Additional treatment medications included was IV fluids and anti-nausea medications.  Patient's wife reported that he had nausea and vomiting since around midnight after the COVID-19 vaccination. Adverse events was not resolved and the subject remain hospitalized at the time of reporting.  Follow-up information received on 30 Sep 2021, the nausea and vomiting were considered as recovered with sequalae on an unknown date.  Company Comment: This case concerns a 61-year-old, male patient with medical history of Metastatic malignant melanoma receiving immunotherapy (ALKS 4230 and pembrolizumab), who experienced the serious unexpected events of nausea and vomiting. The events occurred approximately on the same day after the most recent dose of Spikevax (Moderna COVID-19 vaccine) received as a booster dose. The rechallenge was not applicable since the events occurred after the booster dose without information regarding previous doses. The event was considered related to the vaccine per the reporter's assessment. The medical history of immunotherapy as treatment for metastatic malignant melanoma receiving remain a confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reporter's Comments: Subject experienced events Nausea and Vomiting leading to hospitalized 10 months 11 days after initiating treatment with study drug. The underlying malignancy, melanoma is a confounding factor. Alternate causality was attributed to Covid-19 vaccine booster. There is no indication in this case that the events were attributable to study drugs, Hence, sponsor concurs with the investigator and considers the events as not related to ALK4230 and Keytruda.; Sender's Comments: This case concerns a 61-year-old, male patient with medical history of Metastatic malignant melanoma receiving immunotherapy (ALKS 4230 and pembrolizumab), who experienced the serious unexpected events of nausea and vomiting. The events occurred approximately on the same day after the most recent dose of Spikevax (Moderna COVID-19 vaccine) received as a booster dose. The rechallenge was not applicable since the events occurred after the booster dose without information regarding previous doses. The event was considered related to the vaccine per the reporter's assessment. The medical history of immunotherapy as treatment for metastatic malignant melanoma receiving remain a confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.