Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Neoplasm malignant, Polymerase chain reaction, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: COVID-19; CHILLS; DIARRHOEA; SARS-COV-2 TEST POSITIVE; CHOLANGIOCARCINOMA; HEPATIC CANCER; NEOPLASM MALIGNANT; LUNG NEOPLASM MALIGNANT; ABDOMINAL PAIN; ABDOMINAL PAIN UPPER; COMPUTERISED TOMOGRAM THORAX ABNORMAL; DYSPEPSIA; FEELING ABNORMAL; IMMEDIATE POST INJECTION REACTION; MUSCLE SPASMS; SENSORY DISTURBANCE; ULTRASOUND ABDOMEN ABNORMAL; HEADACHE; FATIGUE; PYREXIA; This spontaneous report received from a patient by a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 52 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient do not had any past medical history, current illness and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total (first dose), administered on right arm on 19-MAY-2021 for an unspecified indication. Age at time of vaccination 52 years old. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 19-MAY-2021, after receiving the vaccine patient immediately felt a rushing feeling pass over the body. The headache kicked in a couple hours later and the patient took some Motrin. The headache never went away or subsided for a month. After 3 months of an ongoing headache, the patient made an appointment with a physician. The patient had symptoms of heart burn after getting the vaccine and had bad leg cramps at nights. The doctor told to take some magnesium supplements. The leg cramps and headaches went on for a couple of more months but they eventually did go away. The patient declined getting the booster. On 19-MAY-2021, the patient experienced abdominal pain, abdominal pain upper, computerised tomogram thorax abnormal, dyspepsia, feeling abnormal, immediate post injection reaction, muscle spasms, sensory disturbance, ultrasound abdomen abnormal, headache, fatigue, and pyrexia. Treatment medications included: ibuprofen. On 02-JAN-2022, the patient went to emergency room for abdominal pain and fever. The doctor told her that she had 3 different types of cancer. She had cholangiocarcinoma, liver cancer (Hepatic Cancer) and lung cancer (Lung neoplasm malignant). The patient was prescribed medications and pain killers but she did not take them. The patient only took the nausea medication because the patient had extreme fatigue and nausea. The patient was very tired all the time and did not had leg cramps or headache anymore. On MAR-2022, the patient had covid-19,  sars-cov-2 test positive, The patient had a high fever and chills while being outside in the sun, then she started getting diarrhea and stomach cramping. She felt weird and thought she had an infection so she went to see a doctor and they said she had a covid. The patient had covid headache next day. On an unspecified date in APR-2022, the patient caught covid again with a fever and diarrhea but tested negative at home. She had milder symptoms and when the patient got a PCR Covid-test, it was positive.  Laboratory data included: PCR Positive. On APR-2022, Laboratory data included: COVID-19 virus test negative Negative, and PCR Positive. Laboratory data (dates unspecified) included: CT scan found primary cholangiocarcinoma cancer and lung cancer, and Diagnostic ultrasound found liver cancer.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle spasms, and had not recovered from abdominal pain, covid-19, chills, cholangiocarcinoma, computerised tomogram thorax abnormal, diarrhoea, dyspepsia, fatigue, feeling abnormal, headache, hepatic cancer, immediate post injection reaction, lung neoplasm malignant, neoplasm malignant, pyrexia, sars-cov-2 test positive, sensory disturbance, ultrasound abdomen abnormal, and abdominal pain upper. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000235542. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from the department on 16-JUN-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: This version updates- Product quality complaint investigation result. This new information does not alter prior causality assessment.  20220619149- covid-19 vaccine ad26.cov2.s - Cholangiocarcinoma, Hepatic cancer ,Neoplasm malignant, Lung neoplasm malignant. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.