Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysgeusia, Ear inflammation, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: a severe reaction that has affect trigeminal nerve; hard time talking; With regard to the region of her mouth, she experienced a burning sensation as well as pins and needles; With regard to the region of her mouth, she experienced a burning sensation as well as pins and needles; food tastes funny; sensation of fuzziness on the tongue, as well as swelling; strange feeling on her throat, tongue, jaw and ear, as well as numbness on right side of tongue and gums, on the lingual side; excruciating pain; ear was very inflamed; right side of tongue continued to stay numb" and she had a "hard time talking; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (three Moderna boosters), for COVID-19 immunization. The following information was reported: EAR INFLAMMATION (non-serious) with onset 18Jan2024, outcome "recovering", described as "ear was very inflamed"; PAIN (non-serious) with onset 18Jan2024, outcome "recovering", described as "excruciating pain"; HYPOAESTHESIA ORAL (non-serious) with onset 18Jan2024, outcome "recovering", described as "right side of tongue continued to stay numb" and she had a "hard time talking"; FEELING ABNORMAL (non-serious) with onset 18Jan2024, outcome "recovering", described as "strange feeling on her throat, tongue, jaw and ear, as well as numbness on right side of tongue and gums, on the lingual side"; TRIGEMINAL NERVE DISORDER (medically significant), outcome "recovering", described as "a severe reaction that has affect trigeminal nerve"; SPEECH DISORDER (non-serious), outcome "recovering", described as "hard time talking"; ORAL DISCOMFORT (non-serious), PARAESTHESIA ORAL (non-serious), outcome "recovering" and all described as "With regard to the region of her mouth, she experienced a burning sensation as well as pins and needles"; DYSGEUSIA (non-serious), outcome "recovering", described as "food tastes funny"; SWOLLEN TONGUE (non-serious), outcome "recovering", described as "sensation of fuzziness on the tongue, as well as swelling". The events "a severe reaction that has affect trigeminal nerve", "right side of tongue continued to stay numb" and she had a "hard time talking", "hard time talking", "with regard to the region of her mouth, she experienced a burning sensation as well as pins and needles", "food tastes funny" and "sensation of fuzziness on the tongue, as well as swelling" required physician office visit. The events "strange feeling on her throat, tongue, jaw and ear, as well as numbness on right side of tongue and gums, on the lingual side", "excruciating pain" and "ear was very inflamed" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: (17Apr2024) Unknown results, notes: CT scan in order to rule out tumors. Therapeutic measures were taken as a result of feeling abnormal, pain, ear inflammation.  Clinical course: caller had inquiry regarding a possible correlation between the administration of the "latest Pfizer COVID-19 booster" vaccine and a severe reaction that has affect trigeminal nerve. Caller was interested in any available information regarding the aforementioned topic. Upon further discussion, caller reported that 6-8 weeks after having been administered Pfizer COVID-19 vaccine booster (administered in mid-to-end of Nov2023), she experienced a strange feeling on her throat, tongue, jaw and ear, as well as numbness on right side of tongue and gums, on the lingual side on 18Jan2024. On 18Jan2024, she experienced excruciating pain and ear was very inflamed. She has been to urgent care because of these events and was put on steroids, which did help; however, right side of tongue continued to stay numb, and she had a hard time talking. With regard to the region of her mouth, she experienced a burning sensation as well as pins and needles, and that food tastes funny. She also commented on a sensation of fuzziness on the tongue, as well as swelling. She is "90% back to normal" when compared to 18Jan2024. She also added that she has visited an ENT (one of these instances was two days ago, on 17Apr2024), who had her be subjected to a "CT scan in order to rule out tumors". Prior to the Pfizer COVID-19 booster vaccine, she had received the Moderna COVID-19 vaccine (three Moderna boosters) but had not experienced these side effects. She has read multiple publications which establish a correlation between "neuralgia" and individuals that received the "Pfizer COVID-19 booster vaccine".   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.