Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Fibrin D dimer, Fibrin D dimer increased, Granuloma, Liver function test
Clinical narrative: COUGH; DYSPNOEA EXERTIONAL; ERYTHEMA; EYE PRURITUS; GRANULOMA; LYMPH NODE CALCIFICATION; OROPHARYNGEAL PAIN; OXYGEN SATURATION DECREASED; PERIPHERAL SWELLING; PRURITUS; RESPIRATORY TRACT CONGESTION; MYELOPATHY; ATELECTASIS; CHEST X-RAY NORMAL; SCAN WITH CONTRAST NORMAL; LIVER FUNCTION TEST INCREASED; PYREXIA; MYALGIA; FIBRIN D DIMER INCREASED; ANGIOGRAM PULMONARY NORMAL; COVID-19; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 2075909) concerned a 46 year old female with an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: abnormal liver enzymes, chronic airway obstruction on bilevel positive airway pressure (BiPAP), lung nodule, pulmonary infiltrates, dyspnea, obstructive sleep apnea, circulatory mediastinal adenopathy, hot flashes, obesity, infectious inflammatory histoplasma capsulatum infection, endocrine metabolic diabetes mellitus type 2 in obese, mixed hyperlipidemia associated with type 2 diabetes mellitus, hypothyroidism in adult, other tobacco abuse, lower extremity edema, history of cervical cancer, hypersomnia, depression with anxiety and digestive and allergies with Codeine manifested with hives itching, Clindamycin Compazine manifested with anxiety, Indigotindisulfonate intravenous (IV) contrast manifested with itching, other Penicillin V-Unknown, Reglan (Ci Pigment Blue 63), Sumatriptan manifested with headache nausea, Prochlorperazine manifested with anxiety. Other pre-existing medical conditions included: The Body mass index (BMI) of patient was 30-39.9. She had not yet received booster. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A expiry: Unknown) dose was not reported, 01 total was administered on 15-JUL-2021 to left arm for an unspecified indication. Concomitant medications included Catapres (clonidine), Allegra (fexofenadine hydrochloride), Motrin (ibuprofen), Synthroid (levothyroxine sodium), Proair HFA (Salbutamol sulfate) and vitamin b complex for drug used for unknown indication. On an unspecified date, she was went to emergency room with symptoms and admission was requested for further care and on 19-JAN-2022, tested computed tomography angiogram thorax with IV contrast was resulted negative for pulmonary embolism (PE) with standard protocol computed tomography (CT) angiogram images were obtained through the chest following the administration of intravenous contrast coronal and axial Maximum intensity projection (MIP) 3-D reformations were performed IV Contrast. The amount and type of contrast are recorded in the medical record. At least one of the following dose reduction techniques was utilized. Iterative reconstruction and or automatic exposure control based on body size and indicated PE suspected low intermediate, did fibrin D dimer increased and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tested positive. She received Decadron in emergency room but was not continued on steroids, Benadryl and Solumedrol as pre-treament for IV contrast allergy. Comparison of chest X-ray (CTs) between 15-DEC-2021 and 24-OCT-2021 resulted as the base of Neck Axillae. There was no adenopathy Mediastinum Hila. There were partially calcified lymph nodes consistent with prior granulomatous inflammation cardiovascular. The heart had a normal size. There was no evidence of right heart strain. There was no pericardial effusion. The thoracic aorta was normal in caliber pulmonary arteries. No pulmonary embolism was present lungs and airways. There was minimal sub segmental atelectasis. There was no consolidation and there were no inflammatory opacities. There were diffusely calcified granulomas pleural space. There were no pleural effusions. There was no pneumothorax upper abdomen included portions of the upper abdomen were unremarkable chest wall musculoskeletal. No suspicious bone lesions. There were degenerative changes in the imaged spine. Impression was no evidence of an acute pulmonary embolism or other acute intrathoracic pathology. She noted itching of hands feet and eyes along with hand swelling and erythema Planned epi and pepcid but patient felt better and declined these medications allergy profile updated. On 22-JAN-2022, she had (fever) pyrexia, (congestion) respiratory tract congestion, sore throat (oropharyngeal pain), cough, myalgia (muscle aches) and tested coronavirus disease -19 (COVID-19) positive, myelopathy, atelectasis, dyspnoea exertional, erythema, eye pruritus, granuloma, lymph node calcification, peripheral swelling. On the same day, she went for laboratory test which included oxygen saturation which was decreased. It was reported that she remained stable on room air labs stable improving planned discharge but patient was feeling symptomatically worse with stable vitals. She was monitored an additional night and remained stable on room air (dose number in series 1). She was hospitalized for 3 days (unspecified date) and was discharged in stable condition (unspecified date). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the angiogram pulmonary normal, atelectasis, covid-19, chest x-ray normal, cough, dyspnoea exertional, erythema, eye pruritus, fibrin d dimer increased, granuloma, liver function test increased, lymph node calcification, myalgia, myelopathy, oropharyngeal pain, oxygen saturation decreased, peripheral swelling, pruritus, pyrexia, respiratory tract congestion, sars-cov-2 test positive and scan with contrast normal was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000217506. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance Department on 18-FEB-2022. The following information was updated and incorporated into case narrative: Investigation result added.; Sender's Comments: V1: Additional information in this version is regarding: product quality complaint investigation result. The follow up information does not change the company causality of the previously reported events. 20220230480 - COVID-19 VACCINE AD26.COV2.S- Myelopathy, Covid-19, Cough, erythema, eye pruritis, oropharyngeal pain, oxygen saturation decreased,  peripheral swelling, pruritus, respiratory tract congestion, sars-cov-2 test positive, chest x-ray normal, fibrin d dimer increased, angiogram pulmonary normal, scan with contrast normal,  liver function test increased, fever.  The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable 20220230480 - COVID-19 VACCINE AD26.COV2.S- Atelectasis, Dyspnoea exertional, granuloma, lymph node calcification. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related. 20220230480 - COVID-19 VACCINE AD26.COV2.S- Myalgia. This event(s) is labeled per RSI and is therefore considered potentially related.