Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Therapeutic response unexpected, Vaccination complication
Clinical narrative: arm was red and swollen; felt like crap/ like I had been run over by a truck; arm was red and swollen; cancer was gone/Stage 4 terminal cancer went into remission/tumors in lungs were gone. Was diagnoses as in remission from cholangiocrcinoma; fever of 103; Chills; felt sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (arm was red and swollen), VACCINATION COMPLICATION (felt like crap/ like I had been run over by a truck), PERIPHERAL SWELLING (arm was red and swollen), ILLNESS (felt sick) and THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/Stage 4 terminal cancer went into remission/tumors in lungs were gone. Was diagnoses as in remission from cholangiocrcinoma) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A, 011J20A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia (fibromyalgia) in 2000, Hives and Chemotherapy on 20-Apr-2021. Concurrent medical conditions included Cholangiocarcinoma (Cholangiocarcinoma that had spread to her liver, and settled on her blood vessels, at some point had spread to her lungs.) since 20-Mar-2020, Drug allergy (Zithromax,urticaria - large hives all over face, neck and torso), Shellfish allergy (hives, short of breath to shellfish.), Allergy to intravenous contrast media (allergy to CT dye iodine causes hives) since 2001, Asthma (environmental asthma) since 1998, Hypertension, Lung cancer, Hay fever and Hypersensitivity reaction. Concomitant products included AMLODIPINE BESILATE (AMLODINE [AMLODIPINE BESILATE]) for Blood pressure, IVOSIDENIB (TIBSOVO) for Cancer, METOPROLOL TARTRATE for Hypertension, PREGABALIN (PREGABALIN +PHARMA) for Pain.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 20-Apr-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced ERYTHEMA (arm was red and swollen), VACCINATION COMPLICATION (felt like crap/ like I had been run over by a truck), PERIPHERAL SWELLING (arm was red and swollen), ILLNESS (felt sick), THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/Stage 4 terminal cancer went into remission/tumors in lungs were gone. Was diagnoses as in remission from cholangiocrcinoma) and PYREXIA (fever of 103). The patient was treated with HEDERA HELIX DRY LEAF (AVILOP) (oral) from 04-Feb-2021 to 09-Feb-2021 at a dose of 600 mg. At the time of the report, ERYTHEMA (arm was red and swollen), VACCINATION COMPLICATION (felt like crap/ like I had been run over by a truck), PERIPHERAL SWELLING (arm was red and swollen), THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/Stage 4 terminal cancer went into remission/tumors in lungs were gone. Was diagnoses as in remission from cholangiocrcinoma) and PYREXIA (fever of 103) outcome was unknown, ILLNESS (felt sick) had resolved and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: high (High) 103.9. On 06-Feb-2021, Body temperature: high (High) 102.4. On 07-Feb-2021, Body temperature: high (High) 99.9. On 08-Feb-2021, Body temperature: high (High) 97.9.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  The patient had a history of Cholangiocarcinoma that had spread to her liver, and settled on her blood vessels. This also at some point had spread to her lungs. She had about 1 year of chemotherapy and was going through the chemotherapy when she had the first 2 shots. She had her chemotherapy appointments on either the same day or the day before or after receiving the first 2 doses of the Moderna vaccine. Her chemotherapy ended around 20-Apr-2021 and she received follow up PET and CT scans which showed her cancer was gone. She then was sent to a radiation oncologist to radiate her lung tumors, but he also stated her lung cancer had disappeared. She continues to take an oral cancer medication Tibsovo at night. Her docto.r believes that the Moderna vaccine had some influence in helping her cancer's remission. Stage 4 terminal cancer went into remission. CT of abdomen and chest showed tumor nonreactive showed tumors in lungs were gone.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Significant: HCP added, Patient demographic details added, Medical history added, Concomitants added, Lab data added, Start date of events added, Verbatim of event added. additional event added, event outcome updated, Treatment drug added, Booster dose information provided