Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Pyrexia, Rash macular, Skin cancer, Skin disorder
Clinical narrative: NONMELANOMA SKIN CANCER ON TIP OF NOSE; SPOT ON LEFT SIDE OF HEAD THAT GOT PINKISH RED; FOGGY; INSOMNIA/DID NOT SLEEP VERY WELL; COVID VACCINE MADE SICK; Lower back issues and pain; Prostatic disorder; Hurting in diaphragm; liver function test increased; Dizzy; Red spots on top of the head; LOST BLOOD DURING BACK SURGERY/LOT OF BLOOD LOST DURING BACK SURGERY; Back surgery; PRETTY ANEMIC AFTER BACK SURGERY; Fever; Chills; COVID-19/HAD COVID TWICE; Unable to get out of bed; No strength at all after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of SKIN CANCER (NONMELANOMA SKIN CANCER ON TIP OF NOSE) and PROCEDURAL HAEMORRHAGE (LOST BLOOD DURING BACK SURGERY/LOT OF BLOOD LOST DURING BACK SURGERY) in an 81-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 products included non-company products IBRUTINIB (IMBRUVICA) tablet for Chronic lymphoid leukemia and MELOXICAM for Back pain.    The patient's past medical history included Shoulder operation in March 2019, COVID-19 and Bypass surgery in 2017. Concurrent medical conditions included Chronic lymphoid leukemia and Back pain.   On 30-Jun-2018, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose and MELOXICAM (unknown route) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19/HAD COVID TWICE). In 2021, the patient experienced MOBILITY DECREASED (Unable to get out of bed) and ASTHENIA (No strength at all after booster shot). On 29-Oct-2021, the patient experienced CHILLS (Chills). On 30-Oct-2021, the patient experienced PYREXIA (Fever). On 08-Mar-2022, the patient experienced PROCEDURAL HAEMORRHAGE (LOST BLOOD DURING BACK SURGERY/LOT OF BLOOD LOST DURING BACK SURGERY) (seriousness criterion medically significant) and SPINAL OPERATION (Back surgery). In 2022, the patient experienced ANAEMIA POSTOPERATIVE (PRETTY ANEMIC AFTER BACK SURGERY). On an unknown date, the patient experienced SKIN CANCER (NONMELANOMA SKIN CANCER ON TIP OF NOSE) (seriousness criterion medically significant), SKIN DISORDER (SPOT ON LEFT SIDE OF HEAD THAT GOT PINKISH RED), FEELING ABNORMAL (FOGGY), INSOMNIA (INSOMNIA/DID NOT SLEEP VERY WELL), ILLNESS (COVID VACCINE MADE SICK), BACK PAIN (Lower back issues and pain), PROSTATIC DISORDER (Prostatic disorder), DIAPHRAGMALGIA (Hurting in diaphragm), LIVER FUNCTION TEST INCREASED (liver function test increased), DIZZINESS (Dizzy) and RASH MACULAR (Red spots on top of the head). At the time of the report, SKIN CANCER (NONMELANOMA SKIN CANCER ON TIP OF NOSE), PROCEDURAL HAEMORRHAGE (LOST BLOOD DURING BACK SURGERY/LOT OF BLOOD LOST DURING BACK SURGERY), ANAEMIA POSTOPERATIVE (PRETTY ANEMIC AFTER BACK SURGERY), LIVER FUNCTION TEST INCREASED (liver function test increased) and PYREXIA (Fever) was resolving, SPINAL OPERATION (Back surgery), SKIN DISORDER (SPOT ON LEFT SIDE OF HEAD THAT GOT PINKISH RED), FEELING ABNORMAL (FOGGY), INSOMNIA (INSOMNIA/DID NOT SLEEP VERY WELL), ILLNESS (COVID VACCINE MADE SICK), COVID-19 (COVID-19/HAD COVID TWICE), PROSTATIC DISORDER (Prostatic disorder), DIAPHRAGMALGIA (Hurting in diaphragm) and RASH MACULAR (Red spots on top of the head) outcome was unknown, BACK PAIN (Lower back issues and pain) had not resolved and MOBILITY DECREASED (Unable to get out of bed), ASTHENIA (No strength at all after booster shot), DIZZINESS (Dizzy) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: increased. On an unknown date, Prostatic specific antigen: 4.11 4.11. Going up at the moment. On an unknown date, White blood cell count: Went up.         No concomitant medication provided. Treatment information mentioned steroids NOS.  Patient on unknown dates experienced back pain and issues somewhere in between L4 and L5. There was pain to the lower back as well as the diaphragm. Prostate specific antigen was going up, currently was at 4.11. Also had red spots on the top of head and white blood cell count was up too. After getting the booster shot, got chills, fever, could not move out of bed and strength loss. In Mar-2019, the patient had shoulder surgery and on 08-Mar-2022 had back surgery. Patient had paused Imbruvica for these surgeries. He had nonmelanoma skin cancer on tip of nose and it was removed on 29-Apr-2022. He had spot on left side of head that got pinkish red, had insomnia and did not sleep very well, and felt foggy. Patient had COVID twice, each time he had a COVID vaccine, it made him sick.  The reporters causality for events prostate specific antigen levels going up, chills, no strength at all and unable to get out of bed with IMBRUVICA(IBRUTINIB) was no reasonable possibility. The reporter's causality for the event(s) of red spots on top of head with IMBRUVICA(IBRUTINIB) was a reasonable possibility.  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.   CC- This is a spontaneous case concerning an 81-year-old male patient with medical history of chronic lymphoid leukemia, who experienced the unexpected, serious (medically significant) events of Skin cancer, Procedural haemorrhage and the unexpected, non-serious adverse event of special interest of COVID-19. The patient underwent back surgery approximately 4 months after receiving the third dose of mRNA-1273 vaccine and reported to have lost a lot of blood and became anemic after the surgery. The patient had nonmelanoma skin cancer on the tip of nose and reported to had COVID-19 which occurred on unknown date. The skin cancer was removed approximately 6 months after receiving the third dose of mRNA-1273. Clinical course, relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Skin cancer and Procedural haemorrhage were resolving and the outcome of the event COVID-19 was unknown. Chronic lymphoid leukemia remains a risk factor for the events of Skin cancer and Procedural haemorrhage. Surgical procedure of the back remains a risk factor for the event Procedural haemorrhage. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant information. Medical history labs, therapy start dates, regimen and new events updated. On 08-Feb-2022: Significant follow up. Outcomes of events updated. On 19-Aug-2022: Significant follow up received. Events added. Case seriousness updated as Medically significant. On 23-Aug-2022: Significant follow up received. Dose details of non-company suspect added.; Sender's Comments: This is a spontaneous case concerning an 81-year-old male patient with medical history of chronic lymphoid leukemia, who experienced the unexpected, serious (medically significant) events of Skin cancer, Procedural haemorrhage and the unexpected, non-serious adverse event of special interest of COVID-19. The patient underwent back surgery approximately 4 months after receiving the third dose of mRNA-1273 vaccine and reported to have lost a lot of blood and became anemic after the surgery. The patient had nonmelanoma skin cancer on the tip of nose and reported to had COVID-19 which occurred on unknown date. The skin cancer was removed approximately 6 months after receiving the third dose of mRNA-1273. Clinical course, relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the events Skin cancer and Procedural haemorrhage were resolving and the outcome of the event COVID-19 was unknown. Chronic lymphoid leukemia remains a risk factor for the events of Skin cancer and Procedural haemorrhage. Surgical procedure of the back remains a risk factor for the event Procedural haemorrhage. The benefit-risk relationship of mRNA-1273 is not affected by this report.