 Musculoskeletal: arthralgia and myalgia.  Dermatologic: rash, itching, periorbital edema and local reaction in the site of infusion (swelling, pain, erythema and pruritus).  Endocrine: elevated TSH.  Other: ANA positivity 8.1.1.3 Adverse Event List(s) for GM-CSF Potential side effects of GM-CSF treatment include fever, chills, nausea, vomiting, diarrhea, fatigue, weakness, headache, decreased appetite, facial flushing, bone and muscle pain, local reaction at the site of injections, rashes, low blood pressure, shortness of breath and low blood counts. Rarely patients may develop blood clots, rapid or irregular heartbeats, feeling of faintness, kidney and liver problems, allergic reactions or fluid retention, including potential fluid retention in lungs or around the heart, and keratitis (inflammation of the cornea). 8.2 Adverse Event Characteristics DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 24  CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate treatment areas should have access to a copy of the CTCAE version 4.0. A copy of the CTCAE version 4.0 can be downloaded from the CTEP web site http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm .  For expedited reporting purposes only: - AEs for the agent(s) that are listed above should be reported only if the adverse event varies in nature, intensity or frequency from the expected toxicity information which is provided. - Other AEs for the protocol that do not require expedited reporting are outlined in the next section (Expedited Adverse Event Reporting) under the sub-heading of Protocol-Specific Expedited Adverse Event Reporting Exclusions.  Attribution of the AE: - Definite – The AE is clearly related to the study treatment. - Probable – The AE is likely related to the study treatment. - Possible – The AE may be related to the study treatment. - Unlikely – The AE is doubtfully related to the study treatment. - Unrelated – The AE is clearly NOT related to the study treatment. 8.3 Adverse Event Reporting 8.3.1 In the event of an unanticipated problem or life-threatening complications treating investigators must immediately notify the Overall PI. 8.3.2 Investigators must report to the Overall PI any adverse event (AE) that occurs after the initial dose of study treatment, during treatment, or within 30 days of the last dose of treatment on the local institutional SAE form. 8.3.3 DF/HCC Adverse Event Reporting Guidelines Investigative sites within DF/HCC will report AEs directly to the DFCI Office for Human Research Studies (OHRS) per the DFCI IRB reporting policy. Attribution DF/HCC Reportable A dverse Events(AEs) Gr. 2 & 3 AE Expected Gr. 2 & 3 AE Unexpected Gr. 4 AE Expected Gr. 4 AE Unexpected Gr. 5 AE Expected or Unexpected Unrelated Unlikely Not required Not required 5 calendar days# 5 calendar days 24 hours* Possible Probable Definite Not required 5 calendar days 5 calendar days# 5 calendar days 24 hours* # If listed in protocol as expected and not requiring expedited reporting, event does not need to be reported. * For participants enrolled and actively participating in the study or for AEs occurring within 30 days of the last intervention, the AE should be reported within 1 business day of learning of the event. DF/HCC Protocol #: 18-280 Protocol Version Date: 10.17.2020 25 8.3.4 Protocol-Specific Adverse Event Reporting Exclusions AEs that occur prior to initiation of vaccine will not be captured or reported with the exception of AEs and SAEs that are related to tumor cell harvest and dendritic cell collection. Events that are thought to be related to tumor cell harvest or dendritic cell collection will be captured and reported as an SAE should it meet the DF/HCC as per DF/HCC guidelines. AEs and SAEs will be captured and reported after initiation of vaccine will be captured and reported as per DF/HCC guidelines. Laboratory abnormalities that are not clinically significant and are not related to study treatment will not be captured or reported. 8.4 Reporting to the Food and Drug Administration (FDA) The Overall PI, as study sponsor, will be responsible for all communications with the FDA. The Overall PI will report to the FDA, regardless of the site of occurrence, any serious adverse event that meets the FDA’s criteria for expedited reporting following the reporting requirements and timelines set by the FDA. 8.5 Reporting to the Institutional Biosafety Committee (IBC) Participating investigators will register and report on research protocols involving biohazards (i.e., recombinant DNA or infectious agents) according to the reporting requirements set by their respective IBC. 8.6 Reporting to Hospital Risk Management Participating investigators will report to their local Risk Management office any participant safety reports, sentinel events or unanticipated problems that require reporting per institutional policy. 8.7 Routine Adverse Event Reporting All Adverse Events must be reported in routine study data submissions to the Overall PI on the toxicity case report forms. AEs reported through expedited processes (e.g., reported to the IRB, FDA, etc.) must also be reported in routine study data submissions. 9.