Sex: F
Vaccine: COVID19
Symptoms: Iron overload, Joint effusion, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration
Clinical narrative: Pneumonia; Abdominal wall abscess; Many Methicillin-resistant Staphylococcus aureus(MRSA) positive; Mod large knee effusion; Left inferior pubic ramus fracture; Upper respiratory infection; Acute Chest Syndrome; Iron Overload; COVID-19; Vassoocclusive Sickle crisis; Acute Pain Crisis; Systomatic cholelithiasis; First dose on 4-May-21 and second on 2-Jun-21, experienced COVID-19 after 15 days of second dose; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE CHEST SYNDROME (Acute Chest Syndrome), SICKLE CELL ANAEMIA WITH CRISIS (Vassoocclusive Sickle crisis), PELVIC FRACTURE (Left inferior pubic ramus fracture), PNEUMONIA (Pneumonia), ABDOMINAL WALL ABSCESS (Abdominal wall abscess), STAPHYLOCOCCAL INFECTION (Many Methicillin-resistant Staphylococcus aureus(MRSA) positive), UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection), JOINT EFFUSION (Mod large knee effusion), CHOLELITHIASIS (Systomatic cholelithiasis) , IRON OVERLOAD (Iron Overload), PAIN (Acute Pain Crisis) and COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 041C21A) for COVID-19. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VOXELOTOR (OXBRYTA) for Anemia.    The patient's past medical history included Bronchiectasis (Bronchiectasis without complication) from 12-Feb-2021 to 14-May-2021, Abdominal wall abscess from 29-Aug-2021 to 03-Sep-2021, Iron overload (Iron overload due to repeat red blood cell) from 18-Jul-2016 to 28-Jun-2019, Cholelithiasis (Systomatic cholelithiasis) from 13-Aug-2021 to 16-Aug-2021, Constipation from 20-Sep-2016 to 30-Nov-2018, Acute pain (Acute pain crisis) from 27-Nov-2020 to 09-Dec-2020, Hypoxemia from 27-Nov-2020 to 09-Dec-2020, Mental status changes (Altered mental status) from 30-Nov-2020 to 02-Dec-2020, Acute kidney injury from 27-Nov-2020 to 09-Dec-2020, Acute pain (Acute pain crisis) from 24-Jan-2021 to 04-Feb-2021, Acute kidney injury from 19-Mar-2021 to 26-Mar-2021, Acute pain (Acute pain crisis) from 19-Mar-2021 to 26-Mar-2021, Chronic liver disease (Chronic parenchymal liver disease) from 19-Mar-2021 to 26-Mar-2021 and Blood transfusion (also on 24-SEP-2020, 01-DEC-2020, 30-JAN-2021, 22-MAR-2021, 23-MAR-2021) from 06-May-2020. Concurrent medical conditions included Insomnia since 13-Jul-2006, Asthma (Mild persistent asthma, unspecified whether complicated) since 14-May-2021, Knee pain (Knee pain, bilateral) since 13-Jul-2016, Shoulder pain (Chronic right shoulder pain) since 07-Apr-2017, Avascular necrosis of bone (Avascular necrosis of bones of both hips) since 04-Sep-2015, Chronic kidney disease stage 2 since 07-May-2020, Acute kidney injury since 30-Nov-2018, Diverticulosis (Diverticulosis of large intestine) since 15-Sep-2015, Hyperopia (Hyperopia with presbyopia, bilateral) since 16-Nov-2016, Vitamin D deficiency since 13-Jul-2016, Thrombocytopenia since 17-Aug-2021 and Anemia. Concomitant products included AZITHROMYCIN from 29-Jan-2020 to 29-Jun-2021 for Cough, Upper respiratory infection and Pneumonia, DEFERASIROX from 15-Feb-2019 to 26-May-2021 for Iron overload, OXYCODONE from 07-Nov-2019 to 22-Oct-2021, MORPHINE from 07-Nov-2019 to 07-Oct-2021, HYDROXYUREA from 07-Nov-2019 to 04-Feb-2021, ERGOCALCIFEROL from 29-Jan-2020 to 16-Jul-2021, ACETAMINOPHEN from 29-Jan-2020 to 02-Sep-2021 and FOLIC ACID from 07-Nov-2019 to an unknown date for Sickle cell disease.   On 02-Nov-2020, the patient started VOXELOTOR (OXBRYTA) (unknown route) 1500 milligram once a day. On 09-Dec-2020, VOXELOTOR (OXBRYTA) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, VOXELOTOR (OXBRYTA) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, VOXELOTOR (OXBRYTA) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-May-2021, VOXELOTOR (OXBRYTA) (unknown route) dosage was changed to 1000 milligram once a day and VOXELOTOR (OXBRYTA) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Jun-2021, VOXELOTOR (OXBRYTA) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIARRHOEA (Diarrhea). On 15-May-2021, the patient experienced PAIN (Acute Pain Crisis) (seriousness criterion hospitalization). On 29-Jun-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) (seriousness criterion hospitalization). On 11-Jul-2021, the patient experienced JOINT EFFUSION (Mod large knee effusion) (seriousness criterion hospitalization). On 05-Aug-2021, the patient experienced CHOLELITHIASIS (Systomatic cholelithiasis) (seriousness criterion hospitalization). On 29-Aug-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Many Methicillin-resistant Staphylococcus aureus(MRSA) positive) (seriousness criterion hospitalization) and ABDOMINAL WALL ABSCESS (Abdominal wall abscess) (seriousness criteria hospitalization and medically significant). On 20-Jan-2022, the patient experienced SICKLE CELL ANAEMIA WITH CRISIS (Vassoocclusive Sickle crisis) (seriousness criteria hospitalization and medically significant), COVID-19 (COVID-19) (seriousness criterion hospitalization) and VACCINATION FAILURE (First dose on 4-May-21 and second on 2-Jun-21, experienced COVID-19 after 15 days of second dose). On 11-Mar-2022, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). On 27-Jul-2022, the patient experienced PELVIC FRACTURE (Left inferior pubic ramus fracture) (seriousness criteria hospitalization and medically significant). On 15-Feb-2023, the patient experienced ACUTE CHEST SYNDROME (Acute Chest Syndrome) (seriousness criteria hospitalization and medically significant) and IRON OVERLOAD (Iron Overload) (seriousness criterion hospitalization). The patient was hospitalized from 15-May-2021 to 26-May-2021 due to PAIN, then from 29-Jun-2021 to 01-Jul-2021 due to UPPER RESPIRATORY TRACT INFECTION, then from 11-Jul-2021 to 16-Jul-2021 due to JOINT EFFUSION, then from 05-Aug-2021 to 15-Aug-2021 due to CHOLELITHIASIS, then from 29-Aug-2021 to 03-Sep-2021 due to ABDOMINAL WALL ABSCESS and STAPHYLOCOCCAL INFECTION, then from 20-Jan-2022 to 31-Jan-2022 due to COVID-19 and SICKLE CELL ANAEMIA WITH CRISIS, then from 11-Mar-2022 to 18-Mar-2022 due to PNEUMONIA, then from 27-Jul-2022 to 28-Aug-2022 due to PELVIC FRACTURE, then from 15-Feb-2023 to 13-Mar-2023 due to ACUTE CHEST SYNDROME and IRON OVERLOAD. At the time of the report VACCINATION FAILURE (First dose on 4-May-21 and second on 2-Jun-21, experienced COVID-19 after 15 days of second dose) outcome was unknown. On 04-May-2021, DIARRHOEA (Diarrhea) had resolved. On 26-May-2021, PAIN (Acute Pain Crisis) had resolved. On 01-Jul-2021, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) had resolved. On 16-Jul-2021, JOINT EFFUSION (Mod large knee effusion) had resolved. On 15-Aug-2021, CHOLELITHIASIS (Systomatic cholelithiasis) had resolved. On 03-Sep-2021, STAPHYLOCOCCAL INFECTION (Many Methicillin-resistant Staphylococcus aureus(MRSA) positive) and ABDOMINAL WALL ABSCESS (Abdominal wall abscess) had resolved. On 31-Jan-2022, SICKLE CELL ANAEMIA WITH CRISIS (Vassoocclusive Sickle crisis) and COVID-19 (COVID-19) had resolved. On 18-Mar-2022, PNEUMONIA (Pneumonia) had resolved. On 05-Sep-2022, PELVIC FRACTURE (Left inferior pubic ramus fracture) had resolved. On 13-Mar-2023, ACUTE CHEST SYNDROME (Acute Chest Syndrome) and IRON OVERLOAD (Iron Overload) had resolved.  Patient was on treatment with Morphine 30mg tablet, q12h from 15-May-2021 and took last dose of 15mg, q12h orally on 28-Jul-2022. Hydromorphone 2mg/ml injection at a dose of 1.5mg, q4h from 15-May-2021 to 26-Apr-2023 at a dose of 1mg/ml, IV PCA. Oxycodone immediate release 10mg, q6h, prn from 21-May-2021 to Oxycodone extended release 12hr tablet, 20mg, q12h until 19-Apr-2023. On 29-Jun-2021, Azithromycin 500mg in dextrose 5% 250ml, IVPB. On 24-May-2021 took Acetaminophen tablet 975 mg Q8H PRN and last dose of 975mg tablet on 14-Apr-2023.  On 12-Jul-2021, Diphenhydramine tablet 25mg once 3X to 11-Apr-2023 50mg/ml injection 25mg q6h PRN. From 29-Aug-2021, Vancomycin 1 gram in dextrose 5% 200ml IVPB to 17-Feb-2023 1 gram in dextrose 5% 200ml IVPB once. On 01-Sep-2021 and 03-Sep-2021, she took Sulfamethoxazole-Trimethoprim 400-80 mg per tablet 160mg of trimethoprim, BID and 800-160mg per tablet. On Apr-2021, patient took Loperamide. From 28-Oct-2021 to 07-Nov-2022, patient took Fluticasone propionate 1 spray each nostril QD. From 28-Oct-2021 to 07-Nov-2022, patient took Montelukast 10mg oral nightly to 26-Apr-2023 10mg, nightly. From 28-Oct-2021 to 07-Nov-2022, Famotidine 20mg, oral, TID to 12-Apr-2023 20mg, daily. From 28-Oct-2021 to 07-Nov-2022, Folic acid 1mg, oral, QD to 27-Jul-2022  05-Aug-2022 1mg oral, QD. From 28-Oct-2021 to 07-Nov-2022, Ondansetron disintegrating 4mg oral Q8H to 18-Apr-2023 2mg/ml injection 4mg, q8h, PRN. From 28-Oct-2021 to 07-Nov-2022, Enoxaparin 40mg Subcutaneous, q24h to 15-Apr-2023, 40mg q24h. From 28-Oct-2021 to 30-Oct-2021, Senna 2 tablet oral nightly to 10-Apr-2023 2 tablet oral nightly. The patient was treated with Gabapentin on 01-Nov-2021 to 04-Nov-2021 at a dose of 300mg oral Nightly and last dose was from 21-Jan-2022 to 23-Jan-2022 at a dose of 300mg oral TID. The patient was treated with Cholecalciferol on 23-Nov-2021 to 08-Dec-2021 at a dose of 5000unit oral QD and last dose was from 02-Dec-2022 to 11-Dec-2022 at an dose of 5000 unit oral QD. The patient was treated with ketorolac on 21-Jan-2022 at a dose of 15mg Intramuscular Q6H. The patient was treated with lactulose on 21-Jan-2022 to 01-Feb-2022 at a dose of 20 gram Oral QD to 11-Apr-2023 at a dose of 10 gram/15 mL oral solution 30 gram, bid. The patient was treated with Calcium on 22-Jan-2022 at a dose of 1gram IV once.  The patient was treated with Dextrose on 22-Jan-2022 at a dose 25gram IV once. The patient was treated with Retacrit on 31-Jul-2022 at a dose of 40000 IV once. The patient was treated with Lokelma on 12-Mar-2023 at a dose of oral powder packet 10 gram, 3 (three) times a day to 18-Feb-2023 oral powder packet 10 gram once. The patient was treated with Golytely on 27-Feb-2023 at a dose of oral solution 4,000 mL. The patient was treated with lactated ringers on 23-Feb-2023 at a dose of bolus 500 mL to 11-Apr-2023 bolus 1,000 mL once. The patient was treated with deferoxamine on 06-Mar-2023 at a dose of 1,000 mg in dextrose 5 % 100 mL infusion daily  and last dose was from 19-feb-2023 to 13-03-2023 at a dose of 1,000 mg in dextrose 5 % 100 mL infusion IV QD. The patient was treated with Lidocaine on 20-Feb-2023 at a dose of 4 % patch and last dose on 10-Apr-2023. The patient was treated with Zinc oxide on 22-Feb-2023 and 13-Mar-2023 at a dose of 20 % ointment. The patient was treated with Calcium carbonate on 13-Mar-2023 at chewable tablet 1,000 mg. The patient was treated with Bisacodyl EG on 18-Feb-2023 and 23-Feb-2023 at a dose of tablet 10 mg once and 5mg respectively. The patient was treated with Apixaban on 25-Apr-2023 with tablet 5 mg, q12h. The patient was treated with Heparin lock flush on 24-Apr-2023 at a dose of 10 units/mL injection 5 mL once. The patient was treated with sodium chloride on 01-Mar-2023 at a dose of 0.9 % infusion and last dose on 10-Apr-2023 at a dose of 0.45 % infusion. The patient was treated with polyethylene glycol on 22-Feb-2023 at a dose of 3350 oral powder 17 gram once and last dose on 10-Apr-2023 at a dose of 3350 oral powder 17 gram once. The patient was treated with Hydroxyzine HCL on 15-Apr-2023 at a dose of tablet 25 mg, TID, PRN. The patient was treated with Azithromycin on 29-Jun-2021 at a dose of 500 mg in dextrose 5 % 250 mL IVPB and last dose was on 16-Feb-2023 tablet 500 mg daily. The patient was treated with Piperacillin & Tazobactum on 14-Apr-2023 at a dose of 4.5 g in 100 mL (iso-osm) IVPB every 12 hours and last dose on 26-Apr-2023. The patient was treated with Budesonide & Formoterol on 13-Apr-2023 at a dose of 80- 4.5 mcg/actuation inhaler 2 puff 2 (two) times a day and last dose on 14-Apr-2023 . The patient was treated with Voxelotor on 17-Feb-2023 at a dose of and tab 1,000 mg and 12-Apr-2023. The patient was treated with Norepinephrine on 11-Apr-2023 at a dose of 8 mg in sodium chloride 0.9% 250 mL infusion. The patient was treated with Sevelamer on 15-Apr-2023 at a dose of tablet 800 mg 3 (three) times a day with meals. The patient was treated with Albuterol on 10-Apr-2023 at a dose of 90 mcg/actuation inhaler 2 puff every 6 (six) hours PRN. The patient was treated with Ceftriaxone on 11-Mar-2022 to 15-Mar-2022 at a dose of 1-gram IV QD and last dose on 15-Feb-2023, 1 g in dextrose (iso-osm) 50 mL IVPB every 24 hrs.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Eosinophil count: 7 %. On 15-May-2021, Haematocrit (36-45 %): 19.6 %. On 15-May-2021, Haemoglobin (12.2-15.3 g/dL): 6.3 g/dL. On 15-May-2021, Lymphocyte count: 25 %. On 15-May-2021, Mean cell haemoglobin (27-33 pg): 28.5 pg. On 15-May-2021, Mean cell haemoglobin concentration (33-36 g/dL): 32.1 g/dL. On 15-May-2021, Mean cell volume (80-96 fL): 88.7 fL. On 15-May-2021, Mean platelet volume (8-12 fL): 11.2 fL. On 15-May-2021, Monocyte count: 10 %. On 15-May-2021, Neutrophil count: 54 %. On 15-May-2021, Platelet count (150-400 thousand per cubic millimetre): 274 thousand per cubic millimetre. On 15-May-2021, Red blood cell count: 2.21 million per cubic millimetre. On 15-May-2021, Red cell distribution width increased (12.3-16.6 %): 22.5 %. On 15-May-2021, White blood cell count (4.8-10.8 thousand per cubic millimetre): 8.1 thousand per cubic millimetre. On 29-Jun-2021, Influenza A virus test: Negative. On 30-Jun-2021, Body temperature: 39.8 degree Celsius. On 30-Jun-2021, Influenza B virus test: Negative. On 30-Jun-2021, Respiratory syncytial virus test: (Positive) Abnormal. On 30-Jun-2021, SARS-CoV-2 test: Not detected. On 13-Jul-2021, Eosinophil count: 5 %. On 13-Jul-2021, Haematocrit (36-45 %): 20 %. On 13-Jul-2021, Haemoglobin (12.2-15.3 g/dL): 6.4 g/dL. On 13-Jul-2021, Lymphocyte count: 43 %. On 13-Jul-2021, Mean cell haemoglobin (27-33 pg): 28.4 pg. On 13-Jul-2021, Mean cell haemoglobin concentration (33-36 g/dL): 32 g/dL. On 13-Jul-2021, Mean cell volume (80-96 fL): 88.9 fL. On 13-Jul-2021, Mean platelet volume (8-12 fL): 10.7 fL. On 13-Jul-2021, Monocyte count: 11 %. On 13-Jul-2021, Neutrophil count: 39 %. On 13-Jul-2021, Platelet count (150-400 thousand per cubic millimetre): 310 thousand per cubic millimetre. On 13-Jul-2021, Red blood cell count: 2.25 million per cubic millimetre. On 13-Jul-2021, Red cell distribution width increased (12.3-16.6 %): 22.4 %. On 13-Jul-2021, White blood cell count (4.8-10.8 thousand per cubic millimetre): 9.2 thousand per cubic millimetre. On 15-Jul-2021, X-ray: XR knee AP and lateral - right IMPRESSION: No fracture or malalignment identified. Radiographically mild-appearing OA, with a moderate to large knee joint effusion. Bone infarct questioned in the proximal tibial metaphysis. On 05-Aug-2021, Computerised tomogram: 1. Dysmorphic liver with morphologic changes suspicious for cirrhosis. 2. Cholelithiasis, without CT evidence of cholecystitis. 3. Bilateral renal cortical scarring. No hydronephrosis or renal calculus bilaterally. 4. Bone changes consistent with known history of sickle cell disease. On 10-Aug-2021, Eosinophil count: 4 %. On 10-Aug-2021, Haematocrit (36-45 %): 18.8 %. On 10-Aug-2021, Haemoglobin (12.2-15.3 g/dL): 6.4 g/dL. On 10-Aug-2021, Lymphocyte count: 29 %. On 10-Aug-2021, Mean cell haemoglobin (27-33 pg): 29.2 pg. On 10-Aug-2021, Mean cell haemoglobin concentration (33-36 g/dL): 34 g/dL. On 10-Aug-2021, Mean cell volume (80-96 fL): 85.8 fL. On 10-Aug-2021, Mean platelet volume (8-12 fL): 10.5 fL. On 10-Aug-2021, Monocyte count: 17 %. On 10-Aug-2021, Neutrophil count: 49 %. On 10-Aug-2021, Platelet count (150-400 thousand per cubic millimetre): 187 thousand per cubic millimetre. On 10-Aug-2021, Red blood cell count: 2.19 million per cubic millimetre. On 10-Aug-2021, Red cell distribution width increased (12.3-16.6 %): 24.4 %. On 10-Aug-2021, White blood cell count (4.8-10.8 thousand per cubic millimetre): 7 thousand per cubic millimetre. On 06-Oct-2021, Bilirubin conjugated (Unknown-<0.5 mg/dl): 0.5 mg/dl. On 06-Oct-2021, Blood bilirubin (Unknown-<1.2 mg/dl): 1.3 mg/dl. On 06-Oct-2021, Blood creatinine (Unknown-<1.02 mg/dl): 1.02 mg/dl. On 06-Oct-2021, Serum ferritin (10-150 ng/mL): 2345.3 ng/mL. On 20-Jan-2022, SARS-CoV-2 test: Detected. On 11-Mar-2022, Chest X-ray: Patchy density in right lower lobe consistent with pneumonia or ACS.. PA and lateral chest radiographs suggested.. On 26-Jun-2022, SARS-CoV-2 test: Not Detected. On 27-Jul-2022, X-ray: Cortical irregularity involving the right inferior pubic ramus, new compared to prior radiograph of 12/1/2021 and may represent an age indeterminate fracture. Chronic appearing left inferior pubic ramus fracture. No right hip fracture or dislocation. On 02-Jan-2023, Influenza A virus test: Negative. On 02-Jan-2023, Influenza B virus test: Negative. On 02-Jan-2023, Respiratory syncytial virus test: Negative. On 02-Jan-2023, SARS-CoV-2 test: Not Detected. On 15-Feb-2023, Alanine aminotransferase (Unknown-<30 U/L): 73 U/L. On 15-Feb-2023, Blood alkaline phosphatase (Unknown-<130 U/L): 201 U/L. On 15-Feb-2023, Blood bilirubin (Unknown-<1.2 mg/dl): 1.5 mg/dl. On 15-Feb-2023, Blood chloride (98-108 milliequivalent per litre): 112 milliequivalent per litre. On 15-Feb-2023, Blood glucose (70-140 mg/dl): 130 mg/dl. On 15-Feb-2023, Blood lactate dehydrogenase (Unknown-<240 U/L): 573 U/L. On 15-Feb-2023, Blood sodium (135-145 milliequivalent per litre): 142 milliequivalent per litre. On 15-Feb-2023, Eosinophil count: 11 %. On 15-Feb-2023, Haematocrit (36-45 %): 29.2 %. On 15-Feb-2023, Haemoglobin (12.2-15.3 g/dL): 9.5 g/dL. On 15-Feb-2023, Lymphocyte count: 28 %. On 15-Feb-2023, Mean cell haemoglobin (27-33 pg): 30 pg. On 15-Feb-2023, Mean cell haemoglobin concentration (33-36 g/dL): 32.5 g/dL. On 15-Feb-2023, Mean cell volume (80-96 fL): 92.1 fL. On 15-Feb-2023, Mean platelet volume (8-12 fL): 11.6 fL. On 15-Feb-2023, Monocyte count: 28 %. On 15-Feb-2023, Neutrophil count: 43 %. On 15-Feb-2023, Platelet count (150-400 thousand per cubic millimetre): 377 thousand per cubic millimetre. On 15-Feb-2023, Red blood cell count: 3.17 million per cubic millimetre. On 15-Feb-2023, Red cell distribution width increased (12.3-16.6 %): 17 %. On 15-Feb-2023, White blood cell count (4.8-10.8 thousand per cubic millimetre): 4.2 thousand per cubic millimetre. On 18-Feb-2023, Serum ferritin (10-150 ng/mL): 22389.5 ng/mL. On 19-Feb-2023, Serum ferritin (10-150 ng/mL): 15527.1 ng/mL. On 10-Apr-2023, Alanine aminotransferase (Unknown-<30 U/L): 53 U/L. On 10-Apr-2023, Blood alkaline phosphatase (Unknown-<130 U/L): 192 U/L. On 10-Apr-2023, Blood bilirubin (Unknown-<1.2 mg/dl): 1.7 mg/dl. On 10-Apr-2023, Blood chloride (98-108 milliequivalent per litre): 108 milliequivalent per litre. On 10-Apr-2023, Blood creatinine (Unknown-<1.02 mg/dl): 1.27 mg/dl. On 10-Apr-2023, Blood glucose (70-140 mg/dl): 116 mg/dl. On 10-Apr-2023, Blood sodium (135-145 milliequivalent per litre): 142 milliequivalent per litre. On 10-Apr-2023, Chest X-ray: Mild pulmonary vascular congestion/fluid overload and patchy bibasilar atelectasis versus acute chest syndrome, left slightly more than right. No obvious pleural effusion. No pneumothorax. On 10-Apr-2023, Eosinophil count: 4 %. On 10-Apr-2023, Haematocrit (36-45 %): 24.8 %. On 10-Apr-2023, Haemoglobin (12.2-15.3 g/dL): 8.2 g/dL. On 10-Apr-2023, Lymphocyte count: 22 %. On 10-Apr-2023, Mean cell haemoglobin (27-33 pg): 28.7 pg. On 10-Apr-2023, Mean cell haemoglobin concentration (33-36 g/dL): 33.1 g/dL. On 10-Apr-2023, Mean cell volume (80-96 fL): 86.7 fL. On 10-Apr-2023, Mean platelet volume (8-12 fL): 11.3 fL. On 10-Apr-2023, Monocyte count: 10 %. On 10-Apr-2023, Neutrophil count: 60 %. On 10-Apr-2023, Platelet count (150-400 thousand per cubic millimetre): 191 thousand per cubic millimetre. On 10-Apr-2023, Red blood cell count: 2.86 million per cubic millimetre. On 10-Apr-2023, Red cell distribution width increased (12.3-16.6 %): 19.1 %. On 10-Apr-2023, White blood cell count (4.8-10.8 thousand per cubic millimetre): 7.8 thousand per cubic millimetre.    Patient experienced episodes of Acute Pain Crisis from 11-Jul-2021 to 16-Jul-2021, from 05-Aug-2021 to 15-Aug-2021, 28-Oct-2021 to 07-Nov-2021, 22-Nov-2021 to 08-Dec-2021, 11-Mar-2022 to 18-Mar-2022, 14-May-2022 to 05-Jun-2022, 26-Jun-2022 to 08-Jul-2022, 27-Jul-2022 to 28-Aug-2022, 04-Sep-2022 to 16-Sep-2022, 01-Dec-2022 to 11-Dec-2022, 02-Jan-2023 to 15-Jan-2023, 15-Feb-2023 to 13-Mar-2023. The patient was hospitalized from 11-Jul-2021 to 16-Jul-2021, 05-Aug-2021 to 15-Aug-2021, 28-Oct-2021 to 07-Nov-2021, 22-Nov-2021 to 08-Dec-2021, 11-Mar-2022 to 18-Mar-2022, 14-May-2022 to 05-Jun-2022, 26-Jun-2022 to 08-Jul-2022, 27-Jul-2022 to 28-Aug-2022, 04-Sep-2022 to 16-Sep-2022, 01-Dec-2022 to 11-Dec-2022, 02-Jan-2023 to 15-Jan-2023, 15-Feb-2023 to 13-Mar-2023 due to Acute Pain Crisis. Patient experienced second episode of COVID-19 from 26-Jun-2022 to 08-Jul-2022. The patient was hospitalized from 26-Jun-2022 to 08-Jul-2022 due to COVID-19. Patient experienced second episode of left inferior pubic ramus fracture from 27-Jul-2022 to 05-Sep-2022. The patient was hospitalized from 27-Jul-2022 to 05-Sep-2022 due to left inferior pubic ramus fracture. Patient experienced second episode of Vasso occlusive crisis from 10-Apr-2023 to 25-Apr-2023. The patient was hospitalized from 10-Apr-2023 to 25-Apr-2023 due to Vasso occlusive crisis. Patient experienced second episode of acute kidney injury from 19-Mar-2021 to 26-Mar-2021. The patient was hospitalized from 19-Mar-2021 to 26-Mar-2021 due to acute kidney injury.   Patient presented to ED with fever and abdominal pain. Patient was diagnosed with Postoperative abdominal pain with fever. Her pain was managed with her home regimen of MS contin, plus IV dilaudid. The regimen was advanced as needed to accommodate her pain. During the admission her bilateral neuropathic leg pain became much worse and she was started on gabapentin which significantly improved her symptoms. IV dilaudid was transitioned to PO on 11/6, and she was discharged on 11/7. Patient admitted with pain c/w acute pain crisis in setting of change in weather. Course c/b pre-renal AKI improved with fluids then subsequently developed LE edema treated with lasix. Pain managed with IV dilaudid 1.5Q4PRN and ms morphine 15mg BID (when renal function improved). She was transitioned back to her home pain regimen oxy 10mg Q6PRN and ms morphine 15mg BID which she takes as needed when in acute pain crisis at home. Patient was COVID+ Previously with URI symptoms, now resolved Likely trigger for VOC - not candidate for therapeutics - supportive care patient reports rhinorrhea and URI symptoms 2 weeks ago and chest pain. had a dry cough for a week and a hlaf but otherwise did not notice any URI symptoms, fevers or shortness of breath. Acute pain crisis was reported as SCD complication and not related to OXBRYTA. Patient had Impaired mobility and Decreased endurance. Pt presents with decreased activity tolerance, and overall limited functional mobility. Pt amb safely w/ cane at this time, no LOB. Pt will benefit from more sessions of skilled physical therapy services to maximize functional endurance, and facilitate D/C planning. Patient was started on IV dilaudid 2 mg q4 with good control of her pain. Patient was noted to have O2 saturation at 85-87% during her admission, although she had no respiratory complaints. She was placed on 2L nasal cannula. CXR and VBG unconcerning. RPP 12/2/2022 and strep swabs 12/2/2022 negative. She was able to be titrated down to 1.5mg, however, on 12/5 she was increased back to 2mg q4hrs for persistent pain and found to have Hgb 5.9. Received 1u PRBC with improvement to Hgb to 7.4 and resolution of hypoxia. She was given IV desferoxamine for iron overload (ferritin on admission of 2341). Hgb remained stable since throughout admission. She was weaned back down to 1.6mg q4 and reported improved sx with further management of pain outpatient. Patient again admitted with diffuse body pain c/w typical VOC pain likely in setting of recent flu-like illness. Maintained on 2mg dilaudid Q4 PRN which was quickly decreased to 1Q3h .Increased IV dilaudid to 1.5q3hHb remained stable, pain improving and patient comfortable with discharge home. Her pain was managed with dilaudid 2mg IV q3 PRN, oxycodone ER 20 nightly, and tylenol, lidocaine patch, heat packs, capsaicin cream. At time of discharge, pain regimen weaned to dilaudid 1mg IV q4, oxycodon 5mg PRN and oxycontin 20mg BID and discharged on oral medications. Started on analgesic regimen for VOC with Dilaudid 2mg IV q4h. Given lokelma for K of 5.8. Given Golytely for constipation, started on standing lactulose. Troponin elevated with peak of 1.01, withEKG sinus tachycardia, no ischemic changes. Patient was discharged on the following pain regimen: oxycontin ER 30 mg q8 PRN (one week supply) and hydromorphone 4 mg PRN (24 doses). She was found to have bilateral infiltrates on CXR, hgb to 6.5, hypoxia to 85%, and rales on exam concerning for ACS. She was given 1u pRBCs with appropriate response. She was treated with a 5 day course of CTX and 3 days of azithromycin. She was found to have iron overload with ferritin to peak of 22,389 and she was treated with deferoxamine. At time of discharge will continue home Jadenu 4 tablets daily. Patient took blood transfusions on different dates for whole blood and packed RBC cells also. Blood Transfusion performed on 18-MAY-2021, 30-JUN-2021, 10-AUG-2021, 14-AUG-2021, 15-AUG-2021, 30-AUG-2021, 25-NOV-2021, 29-NOV-2021, 24-JAN-2022, 12-MAR-2022, 16-MAR-2022, 28-JUN-2022, 27-JUL-2022, 27-JUL-2022, 09-SEP-2022, 11-SEP-2022, 24-OCT-2022, 06-DEC-2022, 02-JAN-2023, 17-FEB-2023, 05-MAR-2023, 12-APR-2023, 25-APR-2023. Patient was advised to take cholecystectomy and used different treatments for the adverse events reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with relevant medical history of avascular necrosis of bones of both hips, abdominal wall abscess, iron overload due to red blood cell transfusion, systematic cholelithiasis, thrombocytopenia, who experienced unexpected serious (medically significant /hospitalization) events of acute chest syndrome, sickle cells anemia, pelvic fracture, pneumonia, abdominal wall abscess and unexpected serious (hospitalization) events of staphylococcal infection, upper respiratory infection, joint effusion, cholelithiasis, iron overload, pain and Covid-19 among other non-serious events. The events of acute chest syndrome and iron overload occurred approximately 2 years and 3 months, sickle cells anemia and covid-19  1 year and 2 months, pelvic fracture  1 year and 8 months, pneumonia  1 year and 4 months, abdominal wall abscess and staphylococcal infection  9 months and 28 days, upper respiratory infection  7 months and 28 days, joint effusion  8 months and 10 days, cholelithiasis  9 months and 4 days, pain  6 months and 14 days after the second dose of mRNA-1273 vaccine. Patient had multiple hospitalization over the past two years with treatment adjustment. The medical history and concomitant medication - Oxbryta, remains as confounders. At the time of the report, events were resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with relevant medical history of avascular necrosis of bones of both hips, abdominal wall abscess, iron overload due to red blood cell transfusion, systematic cholelithiasis, thrombocytopenia, who experienced unexpected serious (medically significant /hospitalization) events of acute chest syndrome, sickle cells anemia, pelvic fracture, pneumonia, abdominal wall abscess and unexpected serious (hospitalization) events of staphylococcal infection, upper respiratory infection, joint effusion, cholelithiasis, iron overload, pain and Covid-19 among other non-serious events. The events of acute chest syndrome and iron overload occurred approximately 2 years and 3 months, sickle cells anemia and covid-19  1 year and 2 months, pelvic fracture  1 year and 8 months, pneumonia  1 year and 4 months, abdominal wall abscess and staphylococcal infection  9 months and 28 days, upper respiratory infection  7 months and 28 days, joint effusion  8 months and 10 days, cholelithiasis  9 months and 4 days, pain  6 months and 14 days after the second dose of mRNA-1273 vaccine. Patient had multiple hospitalization over the past two years with treatment adjustment. The medical history and concomitant medication - Oxbryta, remains as confounders. At the time of the report, events were resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.