Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Illness, Injection site pain, Injection site swelling, Localised infection
Clinical narrative: Adrenalectomy; Bone pain; Heart disorder; Gum bleeding; Purple toes syndrome; Soft stools; Fibromyalgia; Loss of voice; body felt hot/ Hot feeling generalized/Localised feeling of warmth; tingling on leg/ Paresthesia lower limb; Edema of lower extremities; arthritis; bruising; Stiff neck; Swollen lymph nodes; Bleeding; Cardiac flutter; Foggy feeling in head; Swelling; Bleeding mouth; Stomach pain; Short of breath; Night sweats; COVID-19; Diarrhea; Spleen disorder; after the shot, her left arm where she received the injection hurt; Sickness; Rectal bleeding; Mobility decreased; Sleep excessive; Feeling cold; her right arm also started hurting later, even though she did not receive the injection in that arm; Injection site swelling; Tiredness; Headache; she had an infection in her arm after she received the covid19 vaccine; Cold hands & feet; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding), CARDIAC FLUTTER (Cardiac flutter) and RECTAL HAEMORRHAGE (Rectal bleeding) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. 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 Diarrhea from 11-Mar-2019 to 13-Mar-2019, Wound bleeding in June 2019, Cramps since 11-Mar-2019, Dizziness on 23-Feb-2019 and Tumorectomy (Tumor removed). Concurrent medical conditions included Chronic lymphocytic leukemia (Chronic lymphocytic leukemia of b-cell type), Night sweats, Bruising, Thyroid disorder NOS, Osteopenia, Osteoporosis, Cushing's syndrome, Fibromyalgia, Thyroid disorder NOS, Drug allergy (phenazopyridine allergy), Allergy to antibiotic (ciprofloxacin allergy), Allergy to antibiotic (sulfa antibiotics allergy), Malnutrition since 23-Feb-2019, Delayed healing of wound since June 2019, Weight loss since 11-Mar-2019, Decreased appetite since 11-Mar-2019, Generalized rash since 11-Mar-2019, Increased tendency to bruise since 11-Mar-2019, Muscle pain since 11-Mar-2019, Tired all the time since 23-Feb-2019, Nose bleeds since 23-Feb-2019, Nausea since 23-Feb-2019, Weakness generalised since 23-Feb-2019 and Blood pressure high (2 years ago, where she had to be hospitalized). Concomitant products included PROPRANOLOL HCL, MONTELUKAST SODIUM, LEVOTHYROXINE SODIUM (SYNTHROID), HYDROCORTISONE, ESTRADIOL, DHEA and ALPRAZOLAM for an unknown indication.   In February 2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2020, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 280 milligram once a day. On 31-May-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. In 2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day and IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 140 milligram once a day. On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PERIPHERAL COLDNESS (Cold hands & feet) and LOCALISED INFECTION (she had an infection in her arm after she received the covid19 vaccine). On 11-Oct-2021, the patient experienced MOBILITY DECREASED (Mobility decreased), HYPERSOMNIA (Sleep excessive), FEELING COLD (Feeling cold), PAIN IN EXTREMITY (her right arm also started hurting later, even though she did not receive the injection in that arm), INJECTION SITE SWELLING (Injection site swelling), FATIGUE (Tiredness) and HEADACHE (Headache). 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), BONE PAIN (Bone pain), CARDIAC DISORDER (Heart disorder), GINGIVAL BLEEDING (Gum bleeding), BLUE TOE SYNDROME (Purple toes syndrome), FAECES SOFT (Soft stools), FIBROMYALGIA (Fibromyalgia), APHONIA (Loss of voice), FEELING HOT (body felt hot/ Hot feeling generalized/Localised feeling of warmth), PARAESTHESIA (tingling on leg/ Paresthesia lower limb), OEDEMA PERIPHERAL (Edema of lower extremities), ARTHRITIS (arthritis), CONTUSION (bruising), MUSCULOSKELETAL STIFFNESS (Stiff neck), LYMPHADENOPATHY (Swollen lymph nodes), SPLEEN DISORDER (Spleen disorder), FEELING ABNORMAL (Foggy feeling in head), SWELLING (Swelling), MOUTH HAEMORRHAGE (Bleeding mouth), ABDOMINAL PAIN UPPER (Stomach pain), DYSPNOEA (Short of breath), NIGHT SWEATS (Night sweats), COVID-19 (COVID-19), DIARRHOEA (Diarrhea) and INJECTION SITE PAIN (after the shot, her left arm where she received the injection hurt). In 2021, LOCALISED INFECTION (she had an infection in her arm after she received the covid19 vaccine) had resolved. In January 2022, RECTAL HAEMORRHAGE (Rectal bleeding) had resolved. At the time of the report, HAEMORRHAGE (Bleeding), BONE PAIN (Bone pain), FIBROMYALGIA (Fibromyalgia), APHONIA (Loss of voice), FEELING HOT (body felt hot/ Hot feeling generalized/Localised feeling of warmth), OEDEMA PERIPHERAL (Edema of lower extremities), ARTHRITIS (arthritis), MUSCULOSKELETAL STIFFNESS (Stiff neck), LYMPHADENOPATHY (Swollen lymph nodes), PERIPHERAL COLDNESS (Cold hands & feet), ILLNESS (Sickness), FEELING ABNORMAL (Foggy feeling in head), ABDOMINAL PAIN UPPER (Stomach pain), DYSPNOEA (Short of breath), NIGHT SWEATS (Night sweats) and DIARRHOEA (Diarrhea) had not resolved, CARDIAC FLUTTER (Cardiac flutter), HYPERSOMNIA (Sleep excessive), FEELING COLD (Feeling cold), FAECES SOFT (Soft stools), CONTUSION (bruising), PAIN IN EXTREMITY (her right arm also started hurting later, even though she did not receive the injection in that arm), COVID-19 (COVID-19), INJECTION SITE SWELLING (Injection site swelling) and FATIGUE (Tiredness) was resolving, MOBILITY DECREASED (Mobility decreased), GINGIVAL BLEEDING (Gum bleeding), BLUE TOE SYNDROME (Purple toes syndrome), PARAESTHESIA (tingling on leg/ Paresthesia lower limb), MOUTH HAEMORRHAGE (Bleeding mouth) and HEADACHE (Headache) had resolved and ADRENALECTOMY (Adrenalectomy), CARDIAC DISORDER (Heart disorder), SPLEEN DISORDER (Spleen disorder), SWELLING (Swelling) and INJECTION SITE PAIN (after the shot, her left arm where she received the injection hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Blood pressure measurement: high. In 2021, Haematocrit: low. In 2021, Haemoglobin: low. In 2021, Red blood cell count: low. On 02-Oct-2021, Blood pressure measurement: increase  200/100. On 11-Oct-2021, Blood pressure measurement: continued to be high. On 14-Oct-2021, Blood pressure measurement: 191/100. On 18-Nov-2021, Haematocrit: low. On 18-Nov-2021, Haemoglobin: low. On 18-Nov-2021, Red blood cell count: low. In December 2021, Blood pressure measurement: high blood pressure was up to 200 is to 100. On an unknown date, Heart rate: Low. On an unknown date, SARS-CoV-2 test: (Positive) positive and (Positive) Positive.         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. A 60-year-old female patient received 2 doses of mRNA-1273 vaccine and experienced medically significant events of haemorrhage, cardiac flutter (AESI) and rectal bleeding. Onset dates of haemorrhage and cardiac flutter were not provided, latency cannot be assessed. Rectal bleeding occurred approximately 3 months after second vaccination. In addition, patient experienced non serious event of COVID-19 (AESI) on an unknown date, among others non serious events. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Relevant concurrent medical condition of chronic lymphocytic leukemia is a risk factor for haemorrhage and rectal bleeding. Co suspect product Ibrutinib could be a contributory factor for haemorrhage, cardiac flutter and rectal bleeding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-631511 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer. A 60-year-old female patient received 2 doses of mRNA-1273 vaccine and experienced medically significant events of haemorrhage, cardiac flutter (AESI) and rectal bleeding. Onset dates of haemorrhage and cardiac flutter were not provided, latency cannot be assessed. Rectal bleeding occurred approximately 3 months after second vaccination. In addition, patient experienced non serious event of COVID-19 (AESI) on an unknown date, among others non serious events. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Relevant concurrent medical condition of chronic lymphocytic leukemia is a risk factor for haemorrhage and rectal bleeding. Co suspect product Ibrutinib could be a contributory factor for haemorrhage, cardiac flutter and rectal bleeding. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.