Reporte zur Charge EU9809

Symptomtext

uncontrolled weeping; thoughts of self harm; extreme startle response; Emotional liability; This is a spontaneous report from a contactable other Healthcare Professional reported for herself. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm right on 11Feb2021 12:00 at age of 44-year-old (Lot Number: EU9809) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included PMDD (premenstrual dysphoric disorder) but controlled by chemical menopause over 3 months, known allergies to shellfish. Concomitant medications included naproxen and elagolix sodium (ORILISSA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose bnt162b2 (Lot number: EL8982) administered in arm left on 21Jan2021 at 11:45 (at age of 44-year-old) at single dose for COVID-19 immunization. The patient experienced emotional liability, uncontrolled weeping, extreme startle response, thoughts of self harm on 12Feb2021 16:00. The events was reported as non-serious and did not result in emergency room visit or physician office visit. Patient received treatment for the adverse events which included clonazepam. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.