Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Condition aggravated, Cough, Dysarthria, Dysphemia
Clinical narrative: My speech is getting worst with continous coughing while talking; stuttering; continous coughing while talking.; Interchange of vaccine product; frequently choking while eating/ choking while eating, especially drinking; dysarthria and choking got worse/ speech is getting worst; Slurred speech; This is a spontaneous report received from a Physician.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Apr2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "mix hyperlipemia" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: ROSUVASTATIN taken for hyperlipidaemia, start date: 30Mar2023. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "frequently choking while eating/ choking while eating, especially drinking", "Slurred speech", "difficulty swallowing", "submandibular lymphadenopathy", "tingling sensation in my tongue", "I felt that I have had trouble moving my tongue to talk", "I felt that I have had trouble moving my tongue to talk"; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Apr2023, outcome "not recovered", described as "Interchange of vaccine product"; DYSARTHRIA (non-serious) with onset Apr2023, outcome "not recovered", described as "Slurred speech"; CONDITION AGGRAVATED (medically significant) with onset Apr2023, outcome "not recovered", described as "dysarthria and choking got worse/ speech is getting worst"; CHOKING (medically significant) with onset Apr2023, outcome "not recovered", described as "frequently choking while eating/ choking while eating, especially drinking"; SPEECH DISORDER (non-serious) with onset 01Jun2023, outcome "not recovered", described as "My speech is getting worst with continous coughing while talking"; COUGH (non-serious) with onset 01Jun2023, outcome "not recovered", described as "continous coughing while talking."; DYSPHEMIA (non-serious) with onset 01Jun2023, outcome "not recovered", described as "stuttering". The events "frequently choking while eating/ choking while eating, especially drinking", "dysarthria and choking got worse/ speech is getting worst", "slurred speech", "my speech is getting worst with continous coughing while talking", "stuttering" and "continous coughing while talking." required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging head: Normal. Therapeutic measures were taken as a result of choking, dysarthria, speech disorder, dysphemia, cough.  Clinical course: The patient was married with 3 children. She had history of mix hyperlipemia and have started Rosuvastatin 5mg since 30Mar2023. After she received her first Covid shot (Moderna), had experienced a tingling sensation in her tongue. Gradually when she wanted to talk, she felt that she have had trouble moving her tongue to talk, frequently choking while eating, especially drinking, and sub mandibular lymphadenopathy. She had received second and third shots (Moderna) as well. She received her fourth shot (Pfizer) at the end of Apr and after two weeks her dysarthria and choking got worse. She have done Brain MRI with and without contrast which is normal. She was examined by Neurosurgeon and Neurologist in (Withheld). They could not find any symptoms except dysarthria and stuttering. Her speech was getting worst with continuous coughing while talking. AE treatment: Medrol pack. If Covid tested post vaccination: No. Known allergies: None. Other medical history: None.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Considering interchange of vaccine, based on the known temporal association the contributory role of company , suspect drug BNT162b2 to the reported event CHOCKING and CONDITION AGGRAVATED cannot be excluded completely. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.