Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Agitation, COVID-19, Hypertension, Insomnia, Muscle twitching
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; SEVERE AGITATION; PARANOID; RACING THOUGHTS; MUSCLE TWITCHING; INSOMNIA; HIGH BLOOD PRESSURE; PANIC; This spontaneous report received from a patient (nurse) via other company (Pfizer) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: auto immune disease and drug allergy. And other pre-existing medical conditions included that patient was a nurse and patient was not pregnant. Patient was taking other medications within 2 weeks of starting of COVID-19. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, 01 in total was administered on 11-MAR-2021;14:00 to left arm for prophylactic vaccination. Age at time of vaccination 53 years old. The batch number was not reported and has been requested. The patient additionally received non-company suspect vaccine included: tozinameran (Pfizer Biontech covid-19 vaccine) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, 01 total was administered on 09-DEC-2021 16:00 to right arm for prophylactic vaccination. Concomitant medications included lisdexamfetamine mesilate, paroxetine hydrochloride, and trazodone hydrochloride.  On 09-MAY-2022, patient received Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin were not reported, batch number: FY0461 and expiry: Jan-2023) dose not reported for treatment of COVID-19. The patient received the course of 4 days of Paxlovid treatment and discontinued on 12-MAY-2022.  On an unspecified date, the patient experienced covid-19, and was hospitalized (dose number in series 2), which led to suspected clinical vaccination failure (dose number in series 1).  On 11-MAY-2022 at 13:00, following the vaccination with tozinameran (Pfizer Biontech covid-19 vaccine) (dose number in series 2) the patient experienced severe agitation, sweating, paranoid, racing thoughts, shivering, muscle twitching, insomnia, high blood pressure, complete panic and heart racing (dose number in series 2). patient was hospitalized for 1 day. she never had symptoms like this on her medication which she was taking since 20 years. patient visited to emergency room and received treatment medications (dates unspecified) valium (diazepam). She did not finish the last 2 days of the drug. Her psychiatrist was notified.  The action taken with tozinameran (Pfizer Biontech covid-19 vaccine) and covid-19 vaccine ad26.cov2.s  was not applicable. The patient was recovering from severe agitation, paranoid, racing thoughts, muscle twitching, insomnia, high blood pressure, and panic, and the outcome of covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint.; Sender's Comments: V0: 20220560492-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  V0: 20220560492-COVID-19 VACCINE AD26.COV2.S-Covid-19,Severe agitation,Paranoid,Racing thoughts,Muscle twitching,Insomina,High blood pressure.Panic. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.