Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Sensory disturbance, Skin discolouration
Clinical narrative: WETTING BED; BRAIN NOT FIRING PROPERLY, FEELS CONFUSION; WOBBLY COORDINATION; NARROWING OF THE SPINE; SWOLLEN HANDS AND FEET; INFLAMED ORGANS; LESIONS ON LIVER; JOINT FEELS SAUSAGES; PURPLE HANDS; BURNING AND SCREAMING PAIN; MULTIPLE HEMANGIOMAS ON LIVER; ARMS, HANDS, FEET GO TO SLEEP; DAILY CHILLS; LEFT ARM WEAKNESS, DEAD SHOULDER, HARD TO GET UP AND HARD TO GET UP OUT OF CAR; EXTREME PAIN IN ARM, SO SORE COULD NOT TOUCH; SPLITTING HEADACHE, DAILY HEADACHES; FACIAL DROOPING; CROHNS DISEASE; DROOLING WHEN TALK; This spontaneous report received from a patient concerned a 46 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: clostridium difficile infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 10-MAY-2021 midday to left arm for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 10-MAY-2021, patient came home and had a headache (splitting and she still has daily headaches) and sore arm. She took Motrin (ibuprofen), slept for 10 hours and woke up in extreme pain, arm so sore could not touch it and then she took Epsom salt (magnesium sulfate) bath. Immediately after nap on unspecified date in May-2021 patient had facial drooping (which had improved but gets bad again when she was tired), drooling when talk, and vomiting violently for 5 days after the vaccination. On an unspecified date, patient's arms, hands, feet went to sleep. She had to take naps. Her joints felt like sausages. Patient experienced no appetite, diarrhea, crohns disease, wetting bed, brain was not firing properly (feeling of confusion). Coordination was wobbly. She had a new disease: narrowing of the spine. Her back felt like a piece of crackling wood. She was not able to walk. She had pain. Her organs were inflamed and experienced daily chills. Patient had swollen purple hands and swollen feet. When she leans over on the counter sometimes she had a hard time getting up and getting out of her car, she had left arm weakness and dead shoulder that made her hard to drive. Patient had screaming and burning pain. She went to the hospital on 19-JUN-2021. Whenever she had spoken to a medical doctor they told her that they do not know. On an unspecified date, Laboratory data included: CT scan (NR: not provided) resulted in multiple inflamed organs, 2.8 cm lesion on liver. Multiple hemangiomas on the liver, wrapping around liver. Cholesterol (NR: not provided) 246 ca protein (crohns was somewhere) where patient mentioned that it seems Guillain Barre reminiscent, and X-ray of lumbar spine, lumbar spine series (NR: not provided) resulted in disc degenerative disease, narrowing of the spinal column in multiple levels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme pain in arm, so sore could not touch, had not recovered from splitting headache, daily headaches, and daily chills, and the outcome of facial drooping, left arm weakness, dead shoulder, hard to get up and hard to get up out of car, arms, hands, feet go to sleep, wetting bed, brain not firing properly, feels confusion, wobbly coordination, narrowing of the spine, inflamed organs, lesions on liver, purple hands, swollen hands and feet, burning and screaming pain, multiple hemangiomas on liver, joint feels sausages, drooling when talk and crohns disease was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817703-COVID-19 VACCINE AD26.COV2.S -Facial drooping and Chron's disease. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.