Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site swelling, Lymphadenopathy, Mobility decreased, Mouth haemorrhage
Clinical narrative: Bleeding; Cardiac flutter; Adrenalectomy; heart issues; excessive bleeding in gums and mouth; episode where toes turned purple; Soft stools; Fibromyalgia; losing voice; her right leg would not move; episode of night sweats; Stomach pain; Stiff neck; Hot feeling generalized; Arthritis; Cold hands & feet; Localised feeling of warmth; Spleen disorder; Low pulse rate to 50s; Bleeding mouth; Bone pain; Bruising; Edema of lower extremities; foggy feeling in head; Swelling; Diarrhea; Paresthesia lower limb; Short of breath; Patient stated that she had some swollen lymph node; the injection hurt and was swollen; Rectal bleeding; Sickness; symptoms from covid-19 vaccine; headache; very tired; Painful R arm; Injection site swelling; MOBILITY DECREASED; sleeping for long periods of time since the shot; body felt very cold; Hematocrit low; Vaccination site infection; Red blood cell count low; Hemoglobin low; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (Rectal bleeding), HAEMORRHAGE (Bleeding) and CARDIAC FLUTTER (Cardiac flutter) in a 62-year-old female 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 Chronic lymphocytic leukemia.    The patient's past medical history included Night sweats, Diarrhea from 11-Mar-2019 to 13-Mar-2019, Weight loss on 11-Mar-2019, Decreased appetite on 11-Mar-2019, Generalized rash on 11-Mar-2019, Bruising on 11-Mar-2019, Muscle pain on 11-Mar-2019, Cramp on 11-Mar-2019, Malnutrition on 23-Feb-2019, Delayed healing of wound in June 2019, Wound bleeding in June 2019, Increased tendency to bruise on 11-Mar-2019, Tired all the time on 23-Feb-2019, Nose bleeds on 23-Feb-2019, Nausea on 23-Feb-2019, Dizziness on 23-Feb-2019, Weakness generalized on 23-Feb-2019 and Tumor excision (removed). Concurrent medical conditions included Ulcerative colitis, Drug allergy (sulfa antibiotics), Drug allergy (phenazopyridine), Allergy to antibiotic (ciprofloxacin), Chronic lymphocytic leukemia (of b-cell type not having achieved remission), Thyroid disorder NOS (issue , thyroid problem), Osteopenia, Osteoporosis (received treatment), Cushing's syndrome, Fibromyalgia and Blood pressure high since 2019. Concomitant products included PROPRANOLOL HCL, MONTELUKAST SODIUM, HYDROCORTISONE, ESTRADIOL, DHEA, ALPRAZOLAM and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In February 2019, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram. On 31-May-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram. In 2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram and IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 280 milligram. In 2021, the patient experienced HAEMATOCRIT DECREASED (Hematocrit low), RED BLOOD CELL COUNT DECREASED (Red blood cell count low), HAEMOGLOBIN DECREASED (Hemoglobin low) and VACCINATION SITE INFECTION (Vaccination site infection). On 11-Oct-2021, the patient experienced FEELING COLD (body felt very cold), HYPERSOMNIA (sleeping for long periods of time since the shot), MOBILITY DECREASED (MOBILITY DECREASED), PAIN IN EXTREMITY (Painful R arm), INJECTION SITE SWELLING (Injection site swelling), FATIGUE (very tired) and HEADACHE (headache). In December 2021, the patient experienced COVID-19 (symptoms from covid-19 vaccine). In January 2022, the patient experienced RECTAL HAEMORRHAGE (Rectal bleeding) (seriousness criterion medically significant) and ILLNESS (Sickness). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), CARDIAC FLUTTER (Cardiac flutter) (seriousness criterion medically significant), ADRENALECTOMY (Adrenalectomy), CARDIAC DISORDER (heart issues), GINGIVAL BLEEDING (excessive bleeding in gums and mouth), BLUE TOE SYNDROME (episode where toes turned purple), FAECES SOFT (Soft stools), FIBROMYALGIA (Fibromyalgia), APHONIA (losing voice), HYPOKINESIA (her right leg would not move), NIGHT SWEATS (episode of night sweats), ABDOMINAL PAIN UPPER (Stomach pain), MUSCULOSKELETAL STIFFNESS (Stiff neck), FEELING HOT (Hot feeling generalized), ARTHRITIS (Arthritis), PERIPHERAL COLDNESS (Cold hands & feet), FEELING HOT (Localised feeling of warmth), SPLEEN DISORDER (Spleen disorder), HEART RATE DECREASED (Low pulse rate to 50s), MOUTH HAEMORRHAGE (Bleeding mouth), BONE PAIN (Bone pain), CONTUSION (Bruising), OEDEMA PERIPHERAL (Edema of lower extremities), DYSPNOEA (Short of breath), FEELING ABNORMAL (foggy feeling in head), SWELLING (Swelling), DIARRHOEA (Diarrhea), PARAESTHESIA (Paresthesia lower limb), LYMPHADENOPATHY (Patient stated that she had some swollen lymph node) and VACCINATION SITE PAIN (the injection hurt and was swollen). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Upset stomach and Diarrhea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Bone pain, at an unspecified dose and frequency. In 2021, VACCINATION SITE INFECTION (Vaccination site infection) had resolved. In January 2022, RECTAL HAEMORRHAGE (Rectal bleeding) had resolved. At the time of the report, HAEMORRHAGE (Bleeding), FIBROMYALGIA (Fibromyalgia), APHONIA (losing voice), NIGHT SWEATS (episode of night sweats), ABDOMINAL PAIN UPPER (Stomach pain), MUSCULOSKELETAL STIFFNESS (Stiff neck), ARTHRITIS (Arthritis), HAEMATOCRIT DECREASED (Hematocrit low), PERIPHERAL COLDNESS (Cold hands & feet), FEELING HOT (Localised feeling of warmth), HEART RATE DECREASED (Low pulse rate to 50s), ILLNESS (Sickness), BONE PAIN (Bone pain), OEDEMA PERIPHERAL (Edema of lower extremities), DYSPNOEA (Short of breath), FEELING ABNORMAL (foggy feeling in head) and LYMPHADENOPATHY (Patient stated that she had some swollen lymph node) had not resolved, CARDIAC FLUTTER (Cardiac flutter), FAECES SOFT (Soft stools), FEELING COLD (body felt very cold), HYPERSOMNIA (sleeping for long periods of time since the shot), FEELING HOT (Hot feeling generalized), CONTUSION (Bruising), PAIN IN EXTREMITY (Painful R arm), INJECTION SITE SWELLING (Injection site swelling), FATIGUE (very tired) and COVID-19 (symptoms from covid-19 vaccine) was resolving, ADRENALECTOMY (Adrenalectomy), CARDIAC DISORDER (heart issues), HYPOKINESIA (her right leg would not move), SPLEEN DISORDER (Spleen disorder), RED BLOOD CELL COUNT DECREASED (Red blood cell count low), HAEMOGLOBIN DECREASED (Hemoglobin low), SWELLING (Swelling) and VACCINATION SITE PAIN (the injection hurt and was swollen) outcome was unknown and GINGIVAL BLEEDING (excessive bleeding in gums and mouth), BLUE TOE SYNDROME (episode where toes turned purple), MOBILITY DECREASED (MOBILITY DECREASED), MOUTH HAEMORRHAGE (Bleeding mouth), DIARRHOEA (Diarrhea), PARAESTHESIA (Paresthesia lower limb) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2019, Weight: loss. On 14-Oct-2021, Blood pressure measurement: high blood pressure was up to 200 is to 100. On 18-Nov-2021, Haematocrit: low. On 18-Nov-2021, Haemoglobin: low. On 18-Nov-2021, Red blood cell count: low. In December 2021, SARS-CoV-2 test: (Positive) Positive. On an unknown date, Heart rate: pulse was low in the 50s. On an unknown date, SARS-CoV-2 test:.         Patient had to go to the Emergency Room while patient was on Imbruvica for a heart issue. Concomitant medications were including Blood pressure medication and Steroids. It was unknown if patient was enrolled in a COVID-19 vaccine trial.The patient provided the causality assessment between the events excessive bleeding in gums and mouth, high blood pressure, sick to stomach/stomach issues, episode where toes turned purple, heart issues and ibrutinib was Reasonable possibility.The patient provides the causality assessment between the events diarrhea, stomach hurts and tired all the time/fatigue and ibrutinib capsule as reasonable possibility.The patient provided the causality assessment between the events high blood pressure, and ibrutinib capsule as reasonable possibility.The patient provided the causality assessment between the events Increased bruising, rash on different parts of body and ibrutinib capsule as reasonable possibility.The patient did not provide the causality assessment between events losing voice, swollen lymph nodes, stiff neck, sick to stomach, adrenal glands removed and ibrutinib. The patient provide the causality assessment between events dizziness, bruising, heart flutter, high blood pressure, bleeding, fatigue and ibrutinib as reasonable possibility.Patient stated that she had initially started Imbruvica about 2 years ago.The patient did not provide the causality assessment between events tingling on leg, Edema and swelling of legs, feet and ankles and arthritis and Ibrutinib. The patient provided the causality assessment between event body felt hot and ibrutinib as No reasonable possibility. The patient provided the causality assessment between event body felt hot and co suspect MODERNA COVID-19 VACCINE as not related.  Patient lost her sense of taste and smell since getting COVID19.  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 concerning a 62-year-old female patient with medical history of chronic lymphocytic leukemia, ulcerative colitis and fibromyalgia, who experienced the unexpected serious (medically significant) events of Rectal haemorrhage, Haemorrhage, the unexpected serious (medically significant) adverse event of special interest of Cardiac flutter and the unexpected non-serious adverse events of special interest of Fibromyalgia, Hypersomnia, Arthritis and COVID-19. The event Hypersomnia started on the same day after receiving the second dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 2 months after receiving the second dose of mRNA-1273. The event Rectal haemorrhage occurred approximately 3 months after receiving the second dose of mRNA-1273. The events Haemorrhage, Fibromyalgia and Arthritis occurred on unknown date. Clinical course, other relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the event Rectal haemorrhage had resolved, the events Haemorrhage, Fibromyalgia and Arthritis had not resolved and the events Cardiac flutter, Hypersomnia and COVID-19 were resolving. Medical history of chronic lymphocytic leukemia remains a risk factor for the event of Haemorrhage. Medical history of ulcerative colitis remains a risk factor for the event of Rectal haemorrhage. Medical history of fibromyalgia remains a risk factor for the event of Fibromyalgia. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-623717 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 62-year-old female patient with medical history of chronic lymphocytic leukemia, ulcerative colitis and fibromyalgia, who experienced the unexpected serious (medically significant) events of Rectal haemorrhage, Haemorrhage, the unexpected serious (medically significant) adverse event of special interest of Cardiac flutter and the unexpected non-serious adverse events of special interest of Fibromyalgia, Hypersomnia, Arthritis and COVID-19. The event Hypersomnia started on the same day after receiving the second dose of mRNA-1273 vaccine. The event COVID-19 occurred approximately 2 months after receiving the second dose of mRNA-1273. The event Rectal haemorrhage occurred approximately 3 months after receiving the second dose of mRNA-1273. The events Haemorrhage, Fibromyalgia and Arthritis occurred on unknown date. Clinical course, other relevant diagnostic tests and further treatment details were not provided in the case. At the time of the report, the event Rectal haemorrhage had resolved, the events Haemorrhage, Fibromyalgia and Arthritis had not resolved and the events Cardiac flutter, Hypersomnia and COVID-19 were resolving. Medical history of chronic lymphocytic leukemia remains a risk factor for the event of Haemorrhage. Medical history of ulcerative colitis remains a risk factor for the event of Rectal haemorrhage. Medical history of fibromyalgia remains a risk factor for the event of Fibromyalgia. The benefit-risk relationship of mRNA-1273 is not affected by this report.