Sex: F
Vaccine: COVID19
Symptoms: Tryptase
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of THROAT TIGHTNESS (Tightness in the throat), PARAESTHESIA ORAL (Tingling lips/tingling tongue), FEELING ABNORMAL (Felt wave of uneasiness) and TACHYCARDIA (Increased heart rate) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L2OA and 028L2OA) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE for Heart disorder, SIMVASTATIN for High cholesterol, UBIDECARENONE (COQ 10), WOMEN'S DAILY and MELATONIN for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 29-Dec-2020, the patient experienced THROAT TIGHTNESS (Tightness in the throat), PARAESTHESIA ORAL (Tingling lips/tingling tongue) and FEELING ABNORMAL (Felt wave of uneasiness). On an unknown date, the patient experienced TACHYCARDIA (Increased heart rate). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 29-Dec-2020, THROAT TIGHTNESS (Tightness in the throat), PARAESTHESIA ORAL (Tingling lips/tingling tongue) and FEELING ABNORMAL (Felt wave of uneasiness) had resolved. At the time of the report, TACHYCARDIA (Increased heart rate) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Allergy test negative: negative (Negative) tested negative for polyethylene glycol allergy.. On 04-Jan-2021, Tryptase: 3.6 (Inconclusive) ryptase level done on 1/4 and that was 3.6 (standard range <11mcg/L).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered THROAT TIGHTNESS (Tightness in the throat), PARAESTHESIA ORAL (Tingling lips/tingling tongue), FEELING ABNORMAL (Felt wave of uneasiness) and TACHYCARDIA (Increased heart rate) to be related.    Patient was admitted to a room in the ER and assessed by the ER MD. During the assessment period, the tip and tongue tingling resolved without any medication.  45 minutes to an hour after receiving the vaccine Patient received Benadryl IV.  3-4 minutes after receiving the Benadryl my throat tightness began to resolve. Then she received Solu Medrol. The throat tightness began to resolve after receiving the Benadryl and before receiving Solu Medrol.  Patient was observed for an hour, all symptoms resolved.  Patient was prescribed prednisone 40 mg daily for 4 days.  At no point patient had any issues with breathing. Vital signs all normal.   Starting the next day and for three days, Patient had episodes of increased heart rate.  Her normal resting HR is 52-62. During these episodes it increased to 90-110 at rest.  It felt like her heart was racing.  The episodes lasted about an hour and had about 4 episodes a day. Later she talked with an immunologist and she thought the increased heart rate was probably related to the prednisone.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: Updates on Dose-1 events/outcome and reporting about Dose-2; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.