Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia, Nausea, Oxygen saturation, Oxygen saturation decreased
Clinical narrative: They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine; His lungs were filled with fluid; After 2nd dose, next day morning at 9AM, he didn't feel well while at work; He had upset stomach; He started feeling light headed while driving/very light headed; When he walked in the house, he was short of breath; Turned gray/about a minute and half later, he turned purple and blue; His oxygen was dropped to low 70s; His BP dropped to 80/50; His entire torso was covered in a rash; Very nauseous; On the way home, he started vomiting; He felt little achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) and PULMONARY OEDEMA (His lungs were filled with fluid) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) (seriousness criteria hospitalization and medically significant), PULMONARY OEDEMA (His lungs were filled with fluid) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to ANAPHYLACTIC REACTION and PULMONARY OEDEMA. At the time of the report, ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine), PULMONARY OEDEMA (His lungs were filled with fluid), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 80/50 (Low) 80/50. On 13-May-2021, Oxygen saturation: low 70s (Low) low 70s.         Patient's concomitant medication included nasal spray.  He was admitted to the hospital. They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine. The patient was discharged from the hospital on 14-May-2021 evening. The patient was treated with Epi-pen and steroids.  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.; Sender'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.