Reporte zur Charge 201A21N

Symptomtext

SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; COULD NOT MOVE ARM; LEFT ARM PAIN; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21N, expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection which further explained as the patient did not undergo clinical testing for diagnostic confirmation. The patient experienced fever, cough, and body aches. The reporter also noted that after initially received the vaccination patient developed a headache that lasted for 2 months and left arm pain such that he could not move his arm for 2 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left arm pain, headache and the outcome of suspected covid-19 infection, suspected clinical vaccination failure and could not move arm was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000213691. This case, from the same reporter is linked to 20220139528 and 20220139639.; Sender's Comments: V0-20220139854-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS