Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Feeling abnormal, Feeling cold, Pharyngeal swelling
Clinical narrative: Respiratory distress; anaphylaxis reaction; feeling dizzyimmediately after vaccine; 11 days of feeling worse and worse; swelling around her throat; very cold immediately after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISTRESS (Respiratory distress) and ANAPHYLACTIC REACTION (anaphylaxis reaction) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY DISTRESS (Respiratory distress) (seriousness criterion medically significant), ANAPHYLACTIC REACTION (anaphylaxis reaction) (seriousness criterion medically significant), DIZZINESS (feeling dizzyimmediately after vaccine), FEELING ABNORMAL (11 days of feeling worse and worse), PHARYNGEAL SWELLING (swelling around her throat) and FEELING COLD (very cold immediately after vaccine). At the time of the report, RESPIRATORY DISTRESS (Respiratory distress), ANAPHYLACTIC REACTION (anaphylaxis reaction), DIZZINESS (feeling dizzyimmediately after vaccine), FEELING ABNORMAL (11 days of feeling worse and worse), PHARYNGEAL SWELLING (swelling around her throat) and FEELING COLD (very cold immediately after vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on unspecified steroids for COVID-19.  Patient reported feeling dizzy and very cold immediately after vaccine. Patient explained that for the next 11 days she felt worse and worse and was beginning to have trouble breathing. She felt a lump in her throat and had swelling around her throat. Patient went to the doctor first who said she was having respiratory distress and sent her across the street to the emergency room. Patient said she was having an anaphylaxis reaction. She was given a breathing treatment which helped and calmed her. Patient took children's Benadryl that she had on hand for her daughter and she thinks that saved her. Patient mentioned having covid-19 last year and never fully recovered. she had been on and off steroids ever since. Had constant respiratory complications. Patient also said that her antibodies test came back negative.  Patient received Benadryl for breathing problem.  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.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Additional information received on 22-Jun-2021: Additional serious events were added and suspect drug start date was updated. On 22-Jun-2021: Upon internal review on 16-SEP-2022 non significant corrections performed to update case received from field. On 23-Jun-2021: Additional information received on 23-Jun-2021 contain no new information.; 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.