Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Taste disorder, Vaccination site pain
Clinical narrative: Smell is off; Nostrils feel of; Felt disconnected to her body and mind; Taste is off; She is very cold; Blood pressure increased; Wasn't feeling good or well; Left arm became really sore; Feel vey tired; Nausea; Difficulty swallowing; Tongue was swelling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing) and SWOLLEN TONGUE (Tongue was swelling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastrointestinal discomfort. Concurrent medical conditions included Vasovagal symptoms and Raynaud's disease. Concomitant products included MULTIVITAMINS [VITAMINS NOS], FISH OIL, VITAMIN D NOS, ESTROVEN and AMMONIUM CHLORIDE, BETAINE HYDROCHLORIDE, PANCREAS EXTRACT, PANCREATIN, PEPSIN, SPLEEN, STEARIC ACID (ZYPAN) for an unknown indication.    On 10-Sep-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021 at 6:30 PM, the patient experienced DYSPHAGIA (Difficulty swallowing) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue was swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced PAROSMIA (Smell is off), NASAL CONGESTION (Nostrils feel of), FEELING ABNORMAL (Felt disconnected to her body and mind), TASTE DISORDER (Taste is off), FEELING COLD (She is very cold), BLOOD PRESSURE INCREASED (Blood pressure increased), MALAISE (Wasn't feeling good or well), VACCINATION SITE PAIN (Left arm became really sore), FATIGUE (Feel vey tired) and NAUSEA (Nausea). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Difficulty swallowing), PAROSMIA (Smell is off), NASAL CONGESTION (Nostrils feel of), FEELING ABNORMAL (Felt disconnected to her body and mind), TASTE DISORDER (Taste is off), FEELING COLD (She is very cold), BLOOD PRESSURE INCREASED (Blood pressure increased), MALAISE (Wasn't feeling good or well), VACCINATION SITE PAIN (Left arm became really sore), FATIGUE (Feel vey tired) and NAUSEA (Nausea) outcome was unknown and SWOLLEN TONGUE (Tongue was swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 151/138 (High) High blood pressure 151/138.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has stated that she called to hospital and assessed and they thought she is having vagovagal and patient notified her doctor. The patient was in emergency room for 4 hours. Laboratory investigations performed on 10 Sep 2021 included EKG (Electrocardiography) and vital signs whose results were not provided. Treatment for the event included steroids.  Company comment: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious events of dysphagia and swollen tongue; unexpected non-serious events of parosmia, nasal congestion, feeling abnormal, taste disorder, feeling cold, blood pressure increased, malaise; expected non-serious events of vaccination site pain, fatigue and nausea. The events occurred on the same day after the first dose of mRNA1273. The rechallenge is not applicable since the second dose is not due at the time of report. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Additional information received as live follow up included patient demographics, relevant history details, concomitant medication details, adverse event details, laboratory investigation details and treatment medication details. The case was upgraded to serious.; Sender's Comments: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious events of dysphagia and swollen tongue; unexpected non-serious events of parosmia, nasal congestion, feeling abnormal, taste disorder, feeling cold, blood pressure increased, malaise; expected non-serious events of vaccination site pain, fatigue and nausea. The events occurred on the same day after the first dose of mRNA1273. The rechallenge is not applicable since the second dose is not due at the time of report. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.