Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Fatigue, Lip pruritus
Clinical narrative: Second dose of the COVID-19 vaccine: tiredness, no energy; Second dose of the COVID-19 vaccine: tiredness, no energy; Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching; Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching; Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching; Second dose of the COVID-19 vaccine: shortness of breath; Second dose of the COVID-19 vaccine: extreme cramping; Second COVID-19 vaccine: involuntary diarrhea; This spontaneous case was reported by a patient and describes the occurrence of MOUTH SWELLING (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), PARAESTHESIA ORAL (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), LIP PRURITUS (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), DYSPNOEA (Second dose of the COVID-19 vaccine: shortness of breath) and MUSCLE SPASMS (Second dose of the COVID-19 vaccine: extreme cramping) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MOUTH SWELLING (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), PARAESTHESIA ORAL (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), LIP PRURITUS (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), DYSPNOEA (Second dose of the COVID-19 vaccine: shortness of breath), MUSCLE SPASMS (Second dose of the COVID-19 vaccine: extreme cramping) and DIARRHOEA (Second COVID-19 vaccine: involuntary diarrhea). On an unknown date, the patient experienced ASTHENIA (Second dose of the COVID-19 vaccine: tiredness, no energy) and FATIGUE (Second dose of the COVID-19 vaccine: tiredness, no energy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 29-Mar-2021, DIARRHOEA (Second COVID-19 vaccine: involuntary diarrhea) had resolved. At the time of the report, MOUTH SWELLING (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), PARAESTHESIA ORAL (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), LIP PRURITUS (Second dose of the COVID-19 vaccine: swelling, tingling in her mouth; lips itching), DYSPNOEA (Second dose of the COVID-19 vaccine: shortness of breath), MUSCLE SPASMS (Second dose of the COVID-19 vaccine: extreme cramping), ASTHENIA (Second dose of the COVID-19 vaccine: tiredness, no energy) and FATIGUE (Second dose of the COVID-19 vaccine: tiredness, no energy) outcome was unknown.            No concomitant medication reported.  No patient history was reported and no investigation assessment was reported    It was reported that patient did not feel any distress. Also taken breathing treatment via nebulizer. Patient take breathing treatment the first and second night 29-Mar-2021 and 30-Mar-2021to just ease any discomfort in chest.  It was stated that gave instruction to take Benadryl every 8hrs and instructed to visit emergency room if felt any swelling in her throat.  Shortness of breath subsided quickly after used inhaler.