Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse food reaction, Anaemia, COVID-19 immunisation, Chromaturia, Constipation
Clinical narrative: During an incident with bleeding, bleeds more than normally would; Anemic; Got diarrhea when ate too much fruit; Muscle stiffness; Sore that scabs over on nose near right nostril; Sore that scabs over on nose near right nostril; Area was getting smaller but bleeds if scab fell off; Swelling of legs; Constipation; Patient had a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination; Patient had a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination; Pains in legs; Patient experienced urine was much darker than normal after took Moderna booster shot; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (During an incident with bleeding, bleeds more than normally would) and ANAEMIA (Anemic) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    The patient's past medical history included Diarrhea. Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 vaccination.   On 07-Jun-2021, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On 07-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 07-Feb-2022, the patient experienced CHROMATURIA (Patient experienced urine was much darker than normal after took Moderna booster shot). On an unknown date, the patient experienced HAEMORRHAGE (During an incident with bleeding, bleeds more than normally would) (seriousness criterion medically significant), ANAEMIA (Anemic) (seriousness criterion medically significant), ADVERSE FOOD REACTION (Got diarrhea when ate too much fruit), MUSCULOSKELETAL STIFFNESS (Muscle stiffness), SKIN ULCER (Sore that scabs over on nose near right nostril), SCAB (Sore that scabs over on nose near right nostril), WOUND HAEMORRHAGE (Area was getting smaller but bleeds if scab fell off), PERIPHERAL SWELLING (Swelling of legs), CONSTIPATION (Constipation), INTERCHANGE OF VACCINE PRODUCTS (Patient had a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination), COVID-19 IMMUNISATION (Patient had a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination) and PAIN IN EXTREMITY (Pains in legs). At the time of the report, HAEMORRHAGE (During an incident with bleeding, bleeds more than normally would), SKIN ULCER (Sore that scabs over on nose near right nostril), SCAB (Sore that scabs over on nose near right nostril) and WOUND HAEMORRHAGE (Area was getting smaller but bleeds if scab fell off) was resolving, ANAEMIA (Anemic) had resolved, ADVERSE FOOD REACTION (Got diarrhea when ate too much fruit), PERIPHERAL SWELLING (Swelling of legs), CONSTIPATION (Constipation), CHROMATURIA (Patient experienced urine was much darker than normal after took Moderna booster shot), INTERCHANGE OF VACCINE PRODUCTS (Patient had a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination), COVID-19 IMMUNISATION (Patient had a dose of Janssen COVID-19 vaccine prior to mRNA-1273 vaccination) and PAIN IN EXTREMITY (Pains in legs) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Muscle stiffness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2022, Red blood cell count: increased. On 16-Feb-2022, White blood cell count: white blood cell count was 230 and was now down to 5. On an unknown date, Red blood cell count: High normal and 12000. On an unknown date, White blood cell count: High normal and 5000.         Patient had no known allergies and no relevant medical history reported. Patient was anemic due to infusions that required transfusions. He had slightly nauseated at times after taking IMBRUVICA but had improved from when he first started taking the medication. He had constipation for which he ate fruit daily to help but if he ate too much fruit then he got diarrhea. Reporter's causality for events red blood cell count abnormal and white blood cell count abnormal was reported as reasonable possibility with respect to Imbruvica drug. Treatment medications were not reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case, reported by a consumer, concerning a 78-year-old male patient with current medication of Ibrutinib (Imbruvica), who experienced the unexpected serious (medically significant) events of Anemia and Haemorrhage reported as hemorrhage aggravated, in the context of a dose of mRNA-1273 as third/booster dose of COVID-19 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had a dose of Janssen COVID-19 vaccine approximately 8 months prior to mRNA-1273 vaccination (Interchange of vaccine products and Revaccination with different COVID-19 vaccine). It was reported that the patient had a sore that scabs over on the right nostril which sometimes opened and bleed easily. Patient felt like he bleed more than he normally would. This prompted consultation with oncologist and blood chemistries were requested with result of anemia which required transfusions. Eventually, patient had a high normal white blood cell and red blood cell had improved. Patient also had constipation for which patient ate fruit daily to help but if he ate too much fruit then he got diarrhea. Patient also experienced had urine was much darker than normal after taking Moderna booster shot for about 2 days. Patient also had swelling of legs which were painful and the swelling was resolving. Patient also had constipation which was managing well. The co-suspect drug Ibrutinib remains as a confounder for the events Anemia and Haemorrhage. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 78-year-old male patient with current medication of Ibrutinib (Imbruvica), who experienced the unexpected serious (medically significant) events of Anemia and Haemorrhage reported as hemorrhage aggravated, in the context of a dose of mRNA-1273 as third/booster dose of COVID-19 vaccine. Latency cannot be properly assessed since event onset date was not provided. Patient had a dose of Janssen COVID-19 vaccine approximately 8 months prior to mRNA-1273 vaccination (Interchange of vaccine products and Revaccination with different COVID-19 vaccine). It was reported that the patient had a sore that scabs over on the right nostril which sometimes opened and bleed easily. Patient felt like he bleed more than he normally would. This prompted consultation with oncologist and blood chemistries were requested with result of anemia which required transfusions. Eventually, patient had a high normal white blood cell and red blood cell had improved. Patient also had constipation for which patient ate fruit daily to help but if he ate too much fruit then he got diarrhea. Patient also experienced had urine was much darker than normal after taking Moderna booster shot for about 2 days. Patient also had swelling of legs which were painful and the swelling was resolving. Patient also had constipation which was managing well. The co-suspect drug Ibrutinib remains as a confounder for the events Anemia and Haemorrhage. The benefit-risk relationship of mRNA-1273 is not affected by this report.