Reporte zur Charge 205A21A RA

Symptomtext

FLANK PAIN; INABILITY TO FALL ASLEEP; HEADACHE; NAUSEA; INABILITY TO URINATE; CONSTIPATION; This spontaneous report received from a patient concerned a 31-year-old male. The patient's height, and weight were not reported. The patient's past medical history included back pain due to car accident a year ago, and dislocated disc in lower back and neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, RA10630, expiry: unknown) dose was not reported, 1 total administered on 19-MAY-2021 for prophylactic vaccination to left deltoid. No concomitant medications were reported. On 19-MAY-2021, for the first week, patient could not sleep at all and had a headache and nausea for about 3-4 days. Then it got better. As per patient, it was easier to sleep at the time of reporting, but still a little harder to fall asleep. Patient reported that he was having constipation and urinations issues since getting the vaccine. It was not painful to go to the bathroom but it took a while. Consumer woke up on 31-MAY-2021, and had excruciating pain in the back, flank area. It was hurting when he tried to move anyway to the left and if he used to touch it. He felt like he wants to scream. Consumer did consult with his PHP regarding the inability to fall asleep and problems with constipation. He was given some sleep medications and advised to take cranberry juice. HCP (health care professional) was not aware of the flank pain that consumer had that day. He was advised to call PHP or go to urgent care to determine cause of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea on MAY-2021, was recovering from inability to fall asleep, and had not recovered from constipation, flank pain, and inability to urinate. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210557948-COVID-19 VACCINE AD26.COV2.S - inability to urinate. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY