Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Lymphadenopathy, Paraesthesia oral, Tongue movement disturbance
Clinical narrative: frequently choking while eating, especially drinking; experienced a tingling sensation in my tongue.; Gradually when I wanted to talk, I felt that I have had trouble moving my tongue to talk; sub mandibular lymphadenopathy; This spontaneous case was reported by a non-health professional and describes the occurrence of CHOKING (frequently choking while eating, especially drinking) in a 57-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy (Unspecified drug) and Hyperlipemia. Concomitant products included ROSUVASTATIN from 30-Mar-2023 to an unknown date.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHOKING (frequently choking while eating, especially drinking) (seriousness criterion medically significant), PARAESTHESIA ORAL (experienced a tingling sensation in my tongue.), TONGUE MOVEMENT DISTURBANCE (Gradually when I wanted to talk, I felt that I have had trouble moving my tongue to talk) and LYMPHADENOPATHY (sub mandibular lymphadenopathy). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at an unspecified dose and frequency. At the time of the report, CHOKING (frequently choking while eating, especially drinking), PARAESTHESIA ORAL (experienced a tingling sensation in my tongue.), TONGUE MOVEMENT DISTURBANCE (Gradually when I wanted to talk, I felt that I have had trouble moving my tongue to talk) and LYMPHADENOPATHY (sub mandibular lymphadenopathy) outcome was unknown.            Concomitant medication not reported.   The patient received her first Covid shot (Moderna), had experienced a tingling sensation in her tongue. Gradually when she wanted to talk, she felt that she 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 April and after two weeks her dysarthria and choking got worse. She had done Brain MRI with and without contrast which was normal. She was examined by Neurosurgeon and Neurologist in Iran. They could not find any symptoms except dysarthria and stuttering. Her speech was getting worst with continuous coughing while talking. The treatment received for the adverse event was Medrol pack prior to vaccination, was the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  Company Comment: This is a spontaneous case concerning a 57 year-old, female patient with no relevant medical history, who experienced the serious (due to medically significant) unexpected, event of Choking and non-serious unexpected events of Tongue movement disturbance, Paraesthesia oral and Lymphadenopathy, which occurred after the first dose of SPIKEVAX COVID-19 VACCINE NOS. Temporal association cannot be assessed due to lack of information on onset date of the events and vaccination date. Patient reported a tingling sensation in the tongue. Gradually when she wanted to talk, she had trouble moving her tongue, she frequently choked while eating, especially drinking, and had a sub mandibular lymphadenopathy. The outcome of the events was not reported. Patient received second and third dose of Moderna vaccine without any adverse events reported. The fourth dose was reported as Tozinameram and patient experienced dysarthria and choking. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.