Sex: M
Vaccine: COVID19
Symptoms: Gingival bleeding, Haematoma, Haemorrhage, Lower limb fracture, Pain in extremity
Clinical narrative: RUBBED EYE AND WHITES IN EYES WERE BLOOD AND FEW DAYS LATER IT LOOKED LIKE BLOOD; MORE BLEEDING THAN USUAL; HEMATOMA ON LEG; DRYNESS AND PEELING AT CUTICLE SITE ON FINGERNAILS/FINGERTIPS WERE DRY AND PAINFUL/DRY PEELING FINGERNAILS; DRYNESS AND PEELING AT CUTICLE SITE ON FINGERNAILS/ DRY PEELING FINGERNAILS; Gum bleeding; RED DOTS ON TONGUE; BANGED LEG; Bruising; Sinus infection; RED DOTS ON LEGS / RED DOTS ON ARMS; TESTED POSITIVE FOR COVID-19; HAD A LUMP UNDER ARM ABOUT THE SIZE OF AN EGG; FINGERTIPS WERE DRY AND PAINFUL; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (RUBBED EYE AND WHITES IN EYES WERE BLOOD AND FEW DAYS LATER IT LOOKED LIKE BLOOD) and HAEMORRHAGE (MORE BLEEDING THAN USUAL) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID, TOCOPHEROL (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]), METOPROLOL SUCCINATE (TOPROL XL), ASPIRIN [ACETYLSALICYLIC ACID], CUCURBITA PEPO OIL, SERENOA REPENS, ZINC GLUCONATE (SAW PALMETTO [CUCURBITA PEPO OIL;SERENOA REPENS;ZINC GLUCONATE]), TELMISARTAN and EVOLOCUMAB (REPATHA) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. On an unknown date, the patient experienced EYE HAEMORRHAGE (RUBBED EYE AND WHITES IN EYES WERE BLOOD AND FEW DAYS LATER IT LOOKED LIKE BLOOD) (seriousness criterion medically significant), HAEMORRHAGE (MORE BLEEDING THAN USUAL) (seriousness criterion medically significant), HAEMATOMA (HEMATOMA ON LEG), DRY SKIN (DRYNESS AND PEELING AT CUTICLE SITE ON FINGERNAILS/FINGERTIPS WERE DRY AND PAINFUL/DRY PEELING FINGERNAILS), SKIN EXFOLIATION (DRYNESS AND PEELING AT CUTICLE SITE ON FINGERNAILS/ DRY PEELING FINGERNAILS), GINGIVAL BLEEDING (Gum bleeding), TONGUE ERYTHEMA (RED DOTS ON TONGUE), LOWER LIMB FRACTURE (BANGED LEG), CONTUSION (Bruising), SINUSITIS (Sinus infection), ERYTHEMA (RED DOTS ON LEGS / RED DOTS ON ARMS), SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID-19), AXILLARY MASS (HAD A LUMP UNDER ARM ABOUT THE SIZE OF AN EGG) and PAIN IN EXTREMITY (FINGERTIPS WERE DRY AND PAINFUL). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency and HERBAL OIL NOS (VITAMIN E [HERBAL OIL NOS]) at an unspecified dose and frequency. At the time of the report, EYE HAEMORRHAGE (RUBBED EYE AND WHITES IN EYES WERE BLOOD AND FEW DAYS LATER IT LOOKED LIKE BLOOD), HAEMORRHAGE (MORE BLEEDING THAN USUAL), HAEMATOMA (HEMATOMA ON LEG), LOWER LIMB FRACTURE (BANGED LEG), CONTUSION (Bruising) and SINUSITIS (Sinus infection) outcome was unknown, DRY SKIN (DRYNESS AND PEELING AT CUTICLE SITE ON FINGERNAILS/FINGERTIPS WERE DRY AND PAINFUL/DRY PEELING FINGERNAILS), SKIN EXFOLIATION (DRYNESS AND PEELING AT CUTICLE SITE ON FINGERNAILS/ DRY PEELING FINGERNAILS) and PAIN IN EXTREMITY (FINGERTIPS WERE DRY AND PAINFUL) had not resolved and GINGIVAL BLEEDING (Gum bleeding), TONGUE ERYTHEMA (RED DOTS ON TONGUE), ERYTHEMA (RED DOTS ON LEGS / RED DOTS ON ARMS), SARS-COV-2 TEST POSITIVE (TESTED POSITIVE FOR COVID-19) and AXILLARY MASS (HAD A LUMP UNDER ARM ABOUT THE SIZE OF AN EGG) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No known allergies were reported. No relevant medical history were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with lotion.  Company Comment: This is a spontaneous case concerning adult male patient with relevant concurrent medical condition of Chronic lymphocytic leukemia. The patient has relevant concomitant medications of Acetylsalicylic acid and Telmisartan. The patient has medication of co-suspect Ibrutinib (Imbruvica) for Chronic lymphocytic leukemia. The patient has no reported vaccination history. The patient experienced the unexpected serious (medically significant) events of eye haemorrhage (rubbed eye and whites in eyes were blood and few days later it looked like blood) and haemorrhage (more bleeding than usual), the unexpected non-serious AESI event of SARS-CoV-2 test positive, and the unexpected non-serious events of dry skin (dryness and peeling at cuticle site on fingernails/fingertips were dry and painful/dry peeling fingernails), skin exfoliation (dryness and peeling at cuticle site on fingernails/dry peeling of fingernails), gingival bleeding, red dots on tongue, banged leg, haematoma (hematoma on leg), bruising, sinus infection, red dots on legs/ red dots on arms, axillary mass (had a lump under arm about the size of an egg) and pain in extremity (fingertips were dry and painful). The event SARS-CoV-2 test positive occurred after unknown number of day(s) after the unknown dose number of mRNA-1273 vaccine administration. The occurrence of the rest of the events was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. It was reported that the patient was treated with Bacitracin + Neomycin Sulfate + Polymyxin B Sulfate (Neosporin), unspecified lotion and Vitamin E. No further clinical information was available for medical review. The concurrent medical condition of Chronic lymphocytic leukemia remain confounders for the events eye haemorrhage, haemorrhage, dry skin, skin exfoliation, gingival bleeding, red dots on tongue, banged leg, haematoma (hematoma on leg), bruising, sinus infection, red dots on legs/ red dots on arms, axillary mass and pain in extremity. The co-suspect medication of Ibrutinib (Imbruvica) remain confounders for the events sinus infection, haemorrhage, gingival bleeding, red dots on tongue, and red dots on legs/ red dots on arms, haematoma (hematoma on leg) and bruising. The concomitant medications of Acetylsalicylic acid and Telmisartan remain confounders for the events eye haemorrhage, haemorrhage, gingival bleeding, red dots on tongue, and red dots on legs/ red dots on arms, haematoma (hematoma on leg) and bruising. The current Covid-19 pandemic remain confounder for SARS-CoV-2 test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning adult male patient with relevant concurrent medical condition of Chronic lymphocytic leukemia. The patient has relevant concomitant medications of Acetylsalicylic acid and Telmisartan. The patient has medication of co-suspect Ibrutinib (Imbruvica) for Chronic lymphocytic leukemia. The patient has no reported vaccination history. The patient experienced the unexpected serious (medically significant) events of eye haemorrhage (rubbed eye and whites in eyes were blood and few days later it looked like blood) and haemorrhage (more bleeding than usual), the unexpected non-serious AESI event of SARS-CoV-2 test positive, and the unexpected non-serious events of dry skin (dryness and peeling at cuticle site on fingernails/fingertips were dry and painful/dry peeling fingernails), skin exfoliation (dryness and peeling at cuticle site on fingernails/dry peeling of fingernails), gingival bleeding, red dots on tongue, banged leg, haematoma (hematoma on leg), bruising, sinus infection, red dots on legs/ red dots on arms, axillary mass (had a lump under arm about the size of an egg) and pain in extremity (fingertips were dry and painful). The event SARS-CoV-2 test positive occurred after unknown number of day(s) after the unknown dose number of mRNA-1273 vaccine administration. The occurrence of the rest of the events was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. It was reported that the patient was treated with Bacitracin + Neomycin Sulfate + Polymyxin B Sulfate (Neosporin), unspecified lotion and Vitamin E. No further clinical information was available for medical review. The concurrent medical condition of Chronic lymphocytic leukemia remain confounders for the events eye haemorrhage, haemorrhage, dry skin, skin exfoliation, gingival bleeding, red dots on tongue, banged leg, haematoma (hematoma on leg), bruising, sinus infection, red dots on legs/ red dots on arms, axillary mass and pain in extremity. The co-suspect medication of Ibrutinib (Imbruvica) remain confounders for the events sinus infection, haemorrhage, gingival bleeding, red dots on tongue, and red dots on legs/ red dots on arms, haematoma (hematoma on leg) and bruising. The concomitant medications of Acetylsalicylic acid and Telmisartan remain confounders for the events eye haemorrhage, haemorrhage, gingival bleeding, red dots on tongue, and red dots on legs/ red dots on arms, haematoma (hematoma on leg) and bruising. The current Covid-19 pandemic remain confounder for SARS-CoV-2 test positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.