Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram abdomen abnormal, Computerised tomogram thorax, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: MYELOPROLIFERATIVE NEOPLASM; CYTOMEGALOVIRUS TEST; SPLENIC INFARCTION; SARS-COV-2 TEST POSITIVE; ABDOMINAL PAIN; MYELOPROLIFERATIVE NEOPLASM; BRONCHIAL WALL THICKENING; SPLENIC INFARCTION; COVID-19; ABDOMINAL PAIN; CONDITION AGGRAVATED; COUGH; COUGH; LUNG OPACITY; LUNG OPACITY; COMPUTERISED TOMOGRAM THORAX ABNORMAL; RHINORRHOEA; EPSTEIN-BARR VIRUS TEST; SPLENOMEGALY; ULTRASOUND DOPPLER ABNORMAL; CHEST X-RAY NORMAL; BRONCHIAL WALL THICKENING; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; COVID-19; COMPUTERISED TOMOGRAM THORAX ABNORMAL; CONDITION AGGRAVATED; CYTOMEGALOVIRUS TEST; RHINORRHOEA; ECHOCARDIOGRAM NORMAL; SPLENOMEGALY; EPSTEIN-BARR VIRUS TEST; CHEST X-RAY NORMAL; LABORATORY TEST; COMPUTERISED TOMOGRAM ABDOMEN ABNORMAL; SARS-COV-2 TEST POSITIVE; LABORATORY TEST; ULTRASOUND DOPPLER ABNORMAL; PYREXIA; PYREXIA; ECHOCARDIOGRAM NORMAL; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2486178) concerned a 73 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: myalgia, pes planus, cough secondary to angiotensin converting enzyme inhibitor (ACE-i), pain due to total left knee replacement, abdominal pain, and edema, and concurrent conditions included: osteoarthritis, trochanteric bursitis, multiple lung nodules, hypertension, renal cyst, obesity, asthma (Mild persistent asthma with mild exacerbation on rescue inhaler), hyperlipidemia, prediabetes, colovesical fistula, HCC (hepatocellular carcinoma), lyme disease, von willebrand disease, infarction of spleen (splenic infarct), drug allergy (Advair Diskus, Duloxetine, Fluticasone, Gabapentin), onion allergy, former smoker (history of smoking), abnormal left thigh lump, and chronic arthritis. The patient experienced joint pain when treated with ciprofloxacin hydrochloride, and myalgia when treated with sertraline, and GI (gastrointestinal) upset and joint pain when treated with doxycycline, and throat swelling when treated with duloxetine hydrochloride, and cough when treated with lisinopril, swelling when treated with metronidazole, and amlodipine besilate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: unknown) dose was not reported, 1 total, administered on 08-NOV-2021 for an unspecified indication. Age at time of vaccination 73 years old. Concomitant medications included allopurinol, aspirin, alprazolam, benzonatate, biotin, calcium carbonate, and celecoxib.  On 06-OCT-2022, the patient presented to emergency department with several months of cough, runny nose (rhinorrhea), fevers, abdominal pain and found to have splenic infarct (D73 5), also covid-19 positive and condition aggravated. Abdominal CT (Computerised tomogram) was done and showed a splenic infarct with splenomegaly. Splenic infarct was thought to be 2/2 recent covid infection. The patient was seen by Hematology who felt in the absence of associated vessel thrombus, itself did not require anticoagulation. Data had shown no benefit with anticoagulation over aspirin for organ infarct. Patient was already on ASA (acetyl salicylic acid) 81 mg daily long term, doctor recommended a short course of increased dose to 325 mg daily per 1 month, empirically in the setting of COVID positive and associated hypercoagulability with this she conceded to two baby ASA tablets (equals to 162 mg) daily. Echocardiogram was negative for cardio-embolic sources (echocardiogram normal). Hematology checked for other viral illnesses that can cause splenomegaly (EBV (epstein-barr virus), CMV (cytomegalovirus) and appropriate to screen for some hematologic conditions like myeloproliferative condition with Jak2/MPN (Janus kinase 2/myeloproliferative neoplasm) and BCR-ABL FISH (Fluorescence In Situ Hybridization) and PNH (Paroxysmal nocturnal hemoglobinuria). Most of these labs (laboratory test) were pending at the time of discharge and will be followed up by hematology who plan to see patient in their clinic outpatient. Chest x-ray did not show any evidence of lung infection. The patient had been on room air with oxygen saturation above 97%. During the hospitalization, patient had a CT chest (computerised tomogram thorax) which showed stable, several a small 1-2 mm solid pulmonary nodule likely benign in etiology. New 3 mm groundglass nodule within the left upper lobe most likely due to infection and inflammation (lung opacity). Mild bronchial wall thickening due to infection or inflammation. No bronchiectasis. No focal airspace consolidation. The patient was placed on a short course of prednisone due to her underlying asthma by Pulmonology. A left UE soft tissue ultrasound (ultrasound doppler abnormal) showed an ill-defined focus of increased echogenicity within the subcutaneous fat of the anterior thigh correlates with the patient's palpable lump. Differential considerations would include a focus of fat inflammation versus a ill-defined hyperechoic mass. MRI LLE (Magnetic resonance imaging left lower extremities) was recommended however, the patient opted to have it done outpatient with her PCP (primary care physician). The patient was discharged in stable condition on 09-OCT-2022. Patient was hospitalized for 3 days. Treatment medications (dates unspecified) included: prednisone, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from myeloproliferative neoplasm, splenic infarction, abdominal pain, bronchial wall thickening, covid-19, condition aggravated, cough, lung opacity, rhinorrhoea, splenomegaly, chest x-ray normal, computerised tomogram abdomen abnormal, computerised tomogram thorax abnormal, cytomegalovirus test, echocardiogram normal, epstein-barr virus test, laboratory test, sars-cov-2 test positive, ultrasound doppler abnormal, and pyrexia. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000258347. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from department on 13-DEC-2022. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1:The additional information in this version is Product quality complaint investigation result. This doesnot alter causality of previously reported events.   20221113313- myeloproliferative neoplasm, splenic infarction, abdominal pain, bronchial wall thickening, covid-19, condition aggravated, cough, lung opacity, rhinorrhea, splenomegaly, chest x-ray normal, computerised tomogram abdomen abnormal, computerised tomogram thorax abnormal, cytomegalovirus test, echocardiogram normal, epstein-barr virus test, laboratory test, sars-cov-2 test positive, ultrasound doppler abnormal, pyrexia. The event shows an incompatible temporal relationship (considering latency of 332 days, vaccination date:08-Nov-2021 and onset: 06-Oct-2022). Therefore, this event is considered inconsistent with vaccine administration.