Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Product administered at inappropriate site, Rash, Skin discolouration, Syncope
Clinical narrative: CHEST PAIN; JOINT INFLAMMATION; LEFT KNEE HAD A BLACKENED RASH LIKE A BURN; GENERAL ILLNESS; CARTILAGE INFLAMMATION; HYPERTENSIVE CRISIS (BLOOD PRESSURE WAS ELEVATED 220/111); URINARY TRACT INFECTION; BLOOD IN URINE; FROZEN SHOULDER; RASH ON CHEST AND LEGS; BLOOD PRESSURE UP AND DOWN; BLOOD CLOT IN LEFT ARM/THROMBOSIS; ANGINA PECTORIS; SYNCOPE; INCORRECT INJECTION SITE; INJECTION SITE PAIN; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS reference number) concerned a 51-year-old female. The patient's height, and weight were not reported. The patient's past medical history included: urinary tract infection (1 UTI in 3-4 years), and increased heart rate (Reaction to lidocaine), and concurrent conditions included: high cholesterol, alcohol use (1 glass of wine once in a while), non-smoker, hypertension (it was always stable and well controlled by medications prior to vaccination) and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: 21-NOV-2021) dose was not reported, 1 total, administered on 13-MAR-2021 at left arm for prophylactic vaccination. Age at time of vaccination 51 years old. Concomitant medications included atenolol and hydrochlorothiazide for hypertension, Asprin (acetylsalicylic acid), Vitamin D3 (colecalciferol), Vitamin B12 (vitamin b12 nos), Vitamin D (ergocalciferol), gabapentin, magnesium, quercetin, and simvastatin for unknown indication. On 13-MAR-2021, the patient experienced injection site pain right away and stated she still had ongoing pain in left arm. The patient reported progression of pain increased over time. On 15-MAR-2021, the patient experienced angina pectoris and syncope. Patient reported developing minor fainting spells and angina for past 10 plus days. A large dried blood clot was noted on the first days of period on 16-MAR-2021. Patient continued to pass large clots while having periods. Patient reported that some personnel who gave an injection incorrectly injected the vaccine outside of the area of the preferred injection zone (product administered at inappropriate site). Patient had not contacted a health care provided but planned to contact next day as symptoms persisted. On 15-APR-2021 or sometime on an unspecified date in APR-2021, patient was diagnosed with blood clot (thrombosis) by ultrasound in left arm and after that she could not move for her arm for several months due to resulting frozen shoulder. The patient reported her blood pressure was up and down for several months and that was out of control beginning in APR-2021 after clot was diagnosed. The patient reported that in the early period after vaccination her left knee had a blackened rash like a burn which has now resolved. On an unknown date in MAY/JUN/JUL-2021, the patient reported rash on chest and legs and noted she was affected by very weird symptoms. From JUN-JUL 2021, the patient reported that she had frozen shoulder which was now resolved after being treated with physical therapy. The patient noted that her arm was permanently injured when she raised arm up and it appeared crooked. On09-MAY-2021, the patient was seen at emergency room for symptoms related to blood clot. Electrocardiogram (EKG), Echocardiogram (Echo) were performed and were determined to be normal at that time. On 09-MAY-2021, Laboratory data included: Computerised tomogram (CAT) scan (not provided) Normal, EKG (not provided) Normal, Echocardiogram (not provided) normal, Fragment D dimer (not provided) Elevated, and Magnetic resonance imaging (MRI) (not provided) Not reported. MRI, D-dimer- was performed at Emergency room. D-dimer was up, CAT scan of lung over concern for embolism was clear. After diagnosis of clot the patient was prescribed apixaban (Eliquis) 5mg and then increased to 10 mg Twice a day (BID) for 1 month and then 5mg Twice a day BID, apixaban (Eliquis) was discontinued in SEP-2021. The patient also reported that she never had urinary tract infection (and then said maybe 1 UTI in 3-4 years), but had urinary tract infection twice in AUG-OCT-2021 since receiving the vaccine. The patient reported blood twice in urine (Blood in urine) (now resolved), with ongoing pain in right lower back/flank, and ongoing inflammation. The patient received meloxicam for inflammation. The patient mentioned general illness and toxins in body. On NOV-2021, Laboratory data included: CAT scan (not provided) clear, and Diagnostic ultrasound (not provided) clear. Patient reported hypertensive crisis occurring in middle of DEC-2021 lasting until about 3 weeks ago (Mar-2022). The patient's blood pressure was elevated to over 200 and the patient had to seek emergency care. The patient also reported chest pain. The patient was seen at the ER room FEB-2022 when blood pressure was over 220/111. Over the past 3 weeks (since March 2022) the patient reported her blood pressure had come down and was now 126/84. The patient's medications were switched and now on 3 different (metoprolol, amlodipine and lisinopril). Laboratory data included: Blood pressure (not provided) 220/111. On 01-FEB-2022, Laboratory data included: EKG (not provided) normal. On an unspecified date, the patient reported ongoing cartilage and joint inflammation. The patient's left shoulder joint most affected, but the inflammation has also migrated to different joints such as other side as well and knee. On an unknown date, Laboratory data included: Blood pressure (not provided) elevated over 200. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from frozen shoulder on OCT-2021, and blood in urine, and left knee had a blackened rash like a burn, was recovering from hypertensive crisis (blood pressure was elevated 220/111), had not recovered from angina pectoris, syncope, blood clot in left arm/thrombosis, cartilage inflammation, urinary tract infection, joint inflammation, and injection site pain, and the outcome of chest pain, rash on chest and legs, blood pressure up and down and incorrect injection site, general illness was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20220414402 and 20210441932.  Additional information was received from patient on 07-APR-2022. It was determined that Manufacturer Case Number was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number (Patient medical history, new events, Laboratory data, concomitant and treatment medications and narrative updated accordingly).; Sender's Comments: This follow up version was created to update following information: relevant information regarding this case will be submitted under Manufacturer Case Number (Patient medical history, new events, Laboratory data, concomitant and treatment medications and narrative updated accordingly. This added information does not alter the causality of previous reported event.  20210437127-COVID-19 VACCINE AD26.COV2.S-- hypertensive crisis (blood pressure was elevated 220/111). 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.   This is a report of a 51 year old female patient, unknown ethnicity, who was noted to have thrombosis and experienced angina pectoris and syncope 2 days after receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Medical, surgical and smoking history were not reported. Concomitant medications were also not reported. The patient has been having fainting spells and angina for the past more than 10 days. Three (3) after receiving the vaccine, the patient had her monthly period and noted to pass large clots throughout her period. The information provided precludes a meaningful medical assessment. Additional information requested.