Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: PARALYSIS(WALK, UNSTEADY,LOSS OF BALANCE,LOSS OF COORDINATION OF LEGS, ARM AND LEGS FOR 10 MIN,PINS AND NEEDLES/TINGLING HANDS,ARMS,LEG AND FEET); SWELLING RIGHT CENTER OF CHEEK TO LEFT CHEEK ALL THE WAY TO EAR LIP TO  CHEEK,DIFFICULTY TO TALK; NUMBNESS IN THE FACE; INTERMITTENT MIDDLE/UPPER BACK PAIN (RIGHT UNDER SHOULDER BLADE); CHEST PAIN; LOSING THAT MUCH WEIGHT; BACK INJURY(FELT A POP ON BACK, AND HAD  DECREASED MOBILITY TO LEGS); EXCRUCIATING PAIN, STARTED IN LEFT UPPER ARM, IRRADIATING TO WRIST; SOFT TISSUE ISSUE (TENDINITIS); ITCHINESS AND BUMPS ON BOTH ARMS, FOREARM AND HAND; PRESSURE PAIN IN CHEST/STERNUM; PAIN AT SITE INJECTION; SWELLING AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 236 pounds, and height was 53 centimeters. The patient's concurrent conditions included prediabetes, some fruit allergies, alcohol user, and cigarette smoker, and the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with estradiol, prednisone steroids, antihistamines, anxiolytics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced swelling at site of injection. On 10-APR-2021, the patient experienced pain at site injection. On 14-APR-2021, the patient experienced pressure pain in chest/sternum and Echocardiogram was done which was normal.  On 17-APR-2021, the patient experienced itchiness and bumps on both arms, forearm and hand. On 18-APR-2021, the patient consulted to orthopedic doctor, who presumed soft tissue issue (tendinitis). On 21-APR-2021, all the sudden, left side of face, patient felt swelling right center of cheek to left cheek all the way to ear swelling lip to cheek, difficulty to talk, paralysis arms and legs for 10 min and felt numbness in the face. Emergency medical technician send her to hospital and admitted for 2 days for observation at hospital. They thought it was a TIA but it was then ruled out and discharged on 22-Apr-2021.  After hospitalization had issues walking, unsteady, did not feel balanced, after a few days balance seemed to come back but felt numbness on feet and arms. On 10-MAY-2021, the patient experienced excruciating pain, started in left upper arm, irradiating to wrist and treated with IV Toradol in emergency room which alleviated the severity of pain, when patient back home used Motrin, which worked. The patient described pain as there was a big rubber band around arm since a couple of weeks after vaccine and somebody grabs by arm with their finger and thumb stated it feels like there was something underneath it.  On 18-JUN-2021, the patient experienced back injury felt a pop on back and had decreased mobility to legs and nurse line recommended ice packs and Motrin. After 3 weeks it get better .On 18-JUN-2021, the patient losing that much weight 236 lbs at time of first episode and now its 193 lbs. On 12-JUL-2021, the patient experienced chest pain.  On 21-JUL-2021, the patient experienced intermittent middle/upper back pain (right under shoulder blade).The patient all the sudden felt overall weakness she sat down but could get up, paralysis of only legs but did not affect arms that much which lasted for lasted about 10 min and emergency medical technician advised go to hospital but her vitals were ok. After episode, she had serious problems walking constant tingling on feet and legs up to just above knees, hands and arms and went to emergency room day after second attack due to issues walking, waited 7.5 hours sitting, blood test was done which was normal and she got referred to neurologist and possible cardiologist, during appointment with doctor patient had chest pain. Doctor, did an Electrocardiogram which was normal and gave a referral for cardiology and neurology.  On JUL-2021, Laboratory data included: Blood test (NR: not provided) normal. Laboratory data (dates unspecified) included: Allergy test (NR: not provided) Not reported (ongoing). Treatment medications (dates unspecified) included: ibuprofen, and ketorolac tromethamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pressure pain in chest/sternum on 14-APR-2021, chest pain, and itchiness and bumps on both arms, forearm and hand on 17-JUL-2021, and swelling at site of injection on 11-APR-2021, was recovering from pain at site injection, and excruciating pain, started in left upper arm, irradiating to wrist, had not recovered from soft tissue issue (tendinitis), back injury(felt a pop on back, and had decreased mobility to legs), paralysis(walk, unsteady, loss of balance, loss of coordination of legs, arm and legs for 10 min, pins and needles/tingling hands, arms, leg and feet), numbness in the face, intermittent middle/upper back pain (right under shoulder blade), and losing that much weight, and the outcome of swelling right center of cheek to left cheek all the way to ear lip to cheek, difficulty to talk was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210760225-covid-19 vaccine ad26.cov2.s-paralysis(walk, unsteady, loss of balance, loss of coordination of legs, arm and legs for 10 min, pins and needles/tingling hands, arms, leg and feet),  swelling right center of cheek to left cheek all the way to ear lip to cheek (difficulty to talk), numbness in the face. This event(s) is considered unassessable. 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). 20210760225-covid-19 vaccine ad26.cov2.s-excruciating pain, started in left upper arm, irradiating to wrist. This event(s) is labeled per RSI and is therefore considered potentially related.