Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Thrombosis
Clinical narrative: BLOOD CLOT IN BOTH LEGS; PAIN; ELEVATED BLOOD PRESSURE; CHEST PALPITATIONS; NERVOUSNESS; AGITATION; BAD HEADACHES; This spontaneous report received from a patient via a company representative via a social media concerned an elderly female with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: recurring urinary tract infection, abdominal cramping, small growth in right breast, and blood clot, and concurrent conditions included: high blood pressure, allergies to perfumes, and allergy to strong smells. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included dicycloverine for abdominal cramping, nitrofurantoin for recurring urinary tract infection, and tamoxifen for small growth in right breast. On an unspecified date, the patient had blood clot in her both legs. Patient was not sure if prior use of Tamoxifen and use of a COVID-19 vaccine led to blood clots. Patient describes blood clots as, patient's legs from the knee to the ankle were swollen, they looked like an elephant's. The patient started taking starter pack of Xarelto (rivaroxaban) on 23-April-2022 following a blood clot in both her legs. The patient was taking 15 mg twice a day for 21 days then switched to single dose of 20mg per day. On an unspecified date in APR-2022, patient had a side effect of real bad headaches the whole time patient was taking 15 mg, and had to go to the Emergency room for headache, pain, and elevated blood pressure. Patient stated they prescribed Norvasc (Amlodipine Besilate) for high blood pressure. On the last day of taking 15 mg Xarelto, patient had the headache, but when patient took the Norvasc, it stopped the headache. Patient stated, patient was so relived about that, patient had gone almost a month of headache. Tylenol extra strength did not help. Patient had headaches almost everyday. She says on 5-MAY-2022, when patient started Norvasc, patient was feeling good for 17 days. On 22-MAY-2022, when patient took the last dose of the packet, headaches started again. Doctor doubled dosage of Norvasc to see if that will counter the headaches and high blood pressure. On 25-MAY-2022, patient took the double dose, and was having a reaction to that. When asked to clarify, patient said the Norvasc led to chest palpitations. On an unspecified date in MAY-2022, when doubled to 5 mg, the palpitations were more noticeable, and patient recounts nervousness and agitation occurred. On 25-MAY-2022, the patient's blood pressure was 157/60 or 157/70 with a headache. Patient stated the minute she took Xarelto and shortly after, the headaches start, they start on the neck and back and travel up to head, and it settles on right ear. On 25-MAY-2022, when patient went to see the doctor the pain was like a grip. A gripping pain on the right side of the head. Patient had gone almost a month of headache. Tylenol extra strength did not help. It is unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. Additional treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in both legs, bad headaches, pain, elevated blood pressure, chest palpitations, nervousness and agitation was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220558244 and 20220561364.; Sender's Comments: V0:20220604023-covid-19 vaccine ad26.cov2.s-Blood clot in both legs. The event(s) has an unknown/unclear 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.