Reporte zur Charge 042A21A-HR

Symptomtext

FELT SHE IS GOING TO DIE; GAGGED ALL OVER HERSELF; VOMITING; COULDN'T WALK/TRIED TO DRAG HERSELF TO BATHROOM; CHILLS; FEVER; FEELING WEAK AND CAN'T DO ANYTHING; TIRED; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple sclerosis, lupus, non alcohol user and non smoker and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A-HR, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-MAR-2021 at 09:15 on right arm for prophylactic vaccination. The concomitant medications included immuno-suppressant medications. On 30-MAR-2021, the patient started experiencing chills which kept getting worse and got fever then started with vomiting and could not walk. The patient Gagged all over herself. The patient felt like she was going die and can't do anything so she called an ambulance. She was hospitalized on 30-Mar-2021 for all night. At hospital patient treated with medication for vomiting and was put on IV and blood test was performed. On 31-Mar-2021, At 13:00 , the patient was discharged from hospital but patient still experience weak, tired and can't do anything. The patient was hospitalized for 1 day. Hospital stated note for visit was Adverse Drug Reaction and instructed for follow up with treating physician in 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt she is going to die, and vomiting, couldn't walk/tried to drag herself to bathroom, chills, and fever on 31-MAR-2021, had not recovered from feeling weak and can't do anything, and tired, and the outcome of gagged all over herself was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210404324-covid-19 vaccine ad26.cov2.s -Vomiting, couldn't walk and tried to drag herself to the bathroom, gagged all over herself, felt like she is going to die. 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. 20210404324-covid-19 vaccine ad26.cov2.s -Fever, chills. These events are labeled per Agency and are therefore considered potentially related.