Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Pain in extremity, Pulmonary embolism
Clinical narrative: HAD BODY ACHE; HAD HEADACHE; PULMONARY EMBOLISM IN BOTH LUNGS; SHORTNESS OF BREATH; CHARLIE HORSE IN LEGS IN MIDDLE OF NIGHT; LOWER EXTREMETIES HURTING AND SWELLING; HAD FLU-LIKE SYMTPOMS; TIRED/LETHARGIC; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient was a non alcohol user and non smoker, and he took vitamins.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unknown) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date progressively 4 days after receiving vaccine the patient had headache and had body ache. On 21-MAR-2021, the patient had flu-like symptoms and felt tired/lethargic. On 24-MAR-2021, the patient had lower extremeties hurting and swelling. On 26-MAR-2021, the patient felt charlie horse in legs in middle of night. On 01-APR-2021, the patient had shortness of breath and he could not catch her breath. At that point patient went to emergency room. In emergency room the patient underwent CT scan and revealed with small clots in lower lobe of both lungs. The patient was treated with 40 mg Eliquis for treatment. The emergency room doctor advised consumer to saw pulmonary specialist and follow up with him primarily. On 15-APR-2021, the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had flu-like symtpoms, and had not recovered from pulmonary embolism in both lungs, lower extremeties hurting and swelling, shortness of breath, tired/lethargic, charlie horse in legs in middle of night, headache, and body ache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 49 year old female patient, African American, who experienced pain on lower extremities and was noted to have small clots in the lower lobes 5 days and 13 days, respectively, after receiving the the COVID-19 vaccine ad26.cov2.s. Patient's height and weight were not reported. Patient is a non smoker and non alcoholic beverage drinker. Past medical history not reported and patient denied taking medications, except vitamins. Four (4) days after receiving the vaccine, patient experienced flu like symptoms. lethargy, headache and body ache which were noted to resolve. Five (5) days after receiving the vaccine, patient developed pain on the lower extremities and patient noted to fell charley horse (muscle spasm and pain). Thirteen (13) days after receiving the vaccine, patient experienced shortness of breath, which prompted consult at the emergency room. CT Scan done revealed small clots in the lower lobe of both lungs. Patient was noted to have pulmonary embolism. The temporal relationship may be consistent but there is insufficient evidence for the vaccine to cause the events; hence this is assessed as indeterminate per causality classification of adverse events following immunization. Additional information requested.