Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: feeling weak; could not stand up; Tremendous pain in legs; Tremendous pain in back; collapsed on carpet; moaning in pain; diagnosed her with bladder tumor and bladder cancer, confirmed it was a 3cm tumor that was non-malignant; had heavy bleeding in the urine, bleeding in urine heavy bleeding; 35 minutes after the injection she had vaginal bleeding; urine was getting less and less with blood.; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER CANCER (diagnosed her with bladder tumor and bladder cancer, confirmed it was a 3cm tumor that was non-malignant) and BLOOD URINE PRESENT (had heavy bleeding in the urine, bleeding in urine heavy bleeding) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 01120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced BLADDER CANCER (diagnosed her with bladder tumor and bladder cancer, confirmed it was a 3cm tumor that was non-malignant) (seriousness criterion medically significant), BLOOD URINE PRESENT (had heavy bleeding in the urine, bleeding in urine heavy bleeding) (seriousness criterion medically significant), VAGINAL HAEMORRHAGE (35 minutes after the injection she had vaginal bleeding) and URINE ABNORMALITY (urine was getting less and less with blood.). On 13-Feb-2021, the patient experienced ASTHENIA (feeling weak), DYSSTASIA (could not stand up), PAIN IN EXTREMITY (Tremendous pain in legs), BACK PAIN (Tremendous pain in back), FALL (collapsed on carpet) and PAIN (moaning in pain). At the time of the report, BLADDER CANCER (diagnosed her with bladder tumor and bladder cancer, confirmed it was a 3cm tumor that was non-malignant), BLOOD URINE PRESENT (had heavy bleeding in the urine, bleeding in urine heavy bleeding), VAGINAL HAEMORRHAGE (35 minutes after the injection she had vaginal bleeding), URINE ABNORMALITY (urine was getting less and less with blood.), ASTHENIA (feeling weak), DYSSTASIA (could not stand up), PAIN IN EXTREMITY (Tremendous pain in legs), BACK PAIN (Tremendous pain in back), FALL (collapsed on carpet) and PAIN (moaning in pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) presented a condition that needs medical interpretation right away, did not have an infection.         The patient underwent numerous spinal injections for pain over and over again since the episode with the second injection. She underwent a million test and thought it was kidney problems, but that was not the case. One doctor diagnosed her with bladder tumor and bladder cancer. He did a stethoscope test and showed a shape that look cancerous and said they would have to take it out. She went to the gynecologist for a second opinion and they confirmed it was a 3 cm tumor that was non-malignant 26-May-2021/She underwent surgery cystoscopy this May-2021. They told her she may experience bleeding for 2 weeks. She had another stethoscope due on 02-Nov-2021. She had another procedure in Nov-2021.  Company comment: This case concerns a 82 year-old female patient with no medical history provided, who experienced the unexpected serious adverse events of Bladder cancer and Blood urine present with other non serious events. The event for Bladder cancer and Blood urine present occurred on the same day the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine).The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up contains updated events asthenia, dysstasia, pain in extremity, back pain, fall and pain.; Sender's Comments: This case concerns a 82 year-old female patient with no medical history provided, who experienced the unexpected serious adverse events of Bladder cancer and Blood urine present with other non serious events. The event for Bladder cancer and Blood urine present occurred on the same day the patient received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine).The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.