Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Laboratory test, Neoplasm malignant, Pain, Vaccination failure
Clinical narrative: STAGE 4 CANCER ALL OVER; SUSPECTED CLINICAL VACCINATION FAILURE; COVID AFTER VACCINE; PAIN FROM THE MIDDLE OF HER CHEST TO THE MIDDLE OF HER BACK UNDER HER ARM ALL THE WAY STRAIGHT ACROSS; This spontaneous report received from a consumer concerned a 76 year old female. Initial information processed along with follow up information received from agency on 09-JAN-2024. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and penicillin allergy (itchy). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported (dose number series 1), administered in NOV-2021 to Right Arm for covid-19 prophylaxis. Batch number was not reported and has been requested. Concomitant medications included lisinopril and unspecified heart medication.  The reporter stated her mother was 76 years old and healthy when she took the Janssen COVID 19 vaccine in NOV-2021. The reporter stated that her mother developed Stage 4 carcinoma and passed away 06-FEB-2022. She stated that her mother had never had cancer...Stage 1, 2, or 3. She stated she doesn't know what happened and she was trying to figure out. She  stated her mother got COVID after the vaccine. Consumer stated her mother never had COVID in 2019, 2020, 2021, or 2022. Consumer stated her mother took the injection and while she was hospitalized there was testing and the tests found lesions on her liver. The consumer's mother had Stage 4 cancer all over. Consumer stated her mother had never been diagnosed with cancer before. Consumer stated that after her mother took the injection she couldn't lift her right arm the next day and had pain from the middle of her chest to the middle of her back under her arm all the way straight across. Consumer stated that in January/February/November her mother had pain and in December she was in and out of the hospital back and forth. Consumer stated her mother was admitted to the hospital on 17-DEC and came home in January. Consumer stated her mother went back to the hospital in January and her mother was limp like a rag doll, had no energy, and had to be carried. Consumer stated that Hospital found the cancer and she took her mother home and she lasted 3 days before passing away. On 06-FEB-2022, the patient passed away. On 06-FEB-2022, the patient died from stage 4 carcinoma. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of stage 4 cancer all over on 06-FEB-2022, and the outcome of covid after vaccine, pain from the middle of her chest to the middle of her back under her arm all the way straight across and suspected clinical vaccination failure was not reported. This report was associated with a product quality complaint and the reference number is 90000309143. The suspected product quality complaint has been confirmed to be Undetermined. The reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  Neoplasm malignant: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: NATURE OF THE EVENT ( Elderly age ) Therefore, these events are considered inconsistent with vaccine administration  Vaccination failure : The event is a special reporting situation and owing to its own nature, it is not possible to attribute this occurrence to the suspect drug. Hence, the causality is considered inconsistent with vaccine administration; Reported Cause(s) of Death: STAGE 4 CARCINOMA