Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bruxism, Cognitive disorder, Confusional state, Disorientation, Electroencephalogram
Clinical narrative: She has a previous diagnosis of central tremor/The booster dose exacerbated her symptoms.; clenching jaw; Now it is like she cannot put sentences together; she woke up disoriented and very frightened; cognitive issues; Everything felt like an alternate place and feeling; nervousness/extremely nervous; she woke up disoriented and very frightened; confusion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 13:00 (Batch/Lot number: unknown) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "central tremor", start date: 2014 (unspecified if ongoing), notes: previous diagnosis of central tremor under treatment with benadryl.; "Essential tremor", start date: 2013 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, lot number EN6200), administration date: 23Feb2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, single, lot number: EN6204), administration date: 16Mar2021, when the patient was 55 years old, for covid 19 immunization. The following information was reported: DISORIENTATION (non-serious) with onset Dec2021, outcome "recovering", CONFUSIONAL STATE (non-serious) with onset Dec2021, outcome "recovering" and all described as "confusion"; FEAR (non-serious) with onset 04Dec2021 02:00, outcome "not recovered", described as "she woke up disoriented and very frightened"; COGNITIVE DISORDER (non-serious) with onset 04Dec2021, outcome "recovering", described as "cognitive issues"; NERVOUSNESS (non-serious) with onset Dec2021, outcome "not recovered", described as "nervousness/extremely nervous"; TREMOR (non-serious), outcome "recovering", described as "She has a previous diagnosis of central tremor/The booster dose exacerbated her symptoms."; BRUXISM (non-serious), outcome "not recovered", described as "clenching jaw"; SPEECH DISORDER (non-serious), outcome "recovering", described as "Now it is like she cannot put sentences together"; FEELING ABNORMAL (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Everything felt like an alternate place and feeling". The events "she woke up disoriented and very frightened", "confusion", "she woke up disoriented and very frightened", "cognitive issues", "nervousness/extremely nervous", "she has a previous diagnosis of central tremor/the booster dose exacerbated her symptoms.", "clenching jaw", "now it is like she cannot put sentences together" and "everything felt like an alternate place and feeling" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of bruxism, speech disorder, feeling abnormal.  Additional information: Patient got the vaccine from her doctor's office organization. Prior Vaccinations (within 4 weeks): no. To the reported events patient started taking 2 Benadryl at night and felt like she was getting better because of that. Patient was Advised to consult with her doctor/healthcare provider about what she had experienced/are experiencing. Because doctor will be most familiar with her medical condition, clinical history and treatment has been conducted and any relevant information to her specific case who can advise patient about the appropriate action to take. Investigation Assessment: No.  The lot number for bnt162b2 was not provided and will be requested during follow up.