Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Anaphylactic reaction; Flu like symptoms; High grade fever; Tired out; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 69-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.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (High grade fever) and FATIGUE (Tired out). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (High grade fever) and FATIGUE (Tired out) had resolved.            No concomitant medications were reported.  Treatment information was not provided  It was reported that she had the 2 doses of the Moderna Covid-19 vaccine on unspecified dates (vaccination card was not available at the time of the call) at a healthcare facility and had a reaction within a minute after the administration of the 2nd dose.   She said she had anaphylactic reaction to whatever substance might be in the vaccine. Paramedics were called and she was advised to go the hospital but she remained at the observation room for 25 minutes until she felt better.   She went home 15 minutes later, tired out from the entire ordeal. The next day, she had flu like symptoms. The symptoms were very strong during the first few days. She had a high grade fever which made her almost go to the hospital. The symptoms lasted for a week.  This case concerns a 69-year-old female patient with no previous relevant medical history, who experienced the serious expected event of Anaphylactic reaction after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred minutes after the second dose of Spikevax. Clinical manifestations included Oropharyngeal discomfort, respiratory disorder and Rash. The event resolved after 25 minutes of observation. No medical intervention was reported. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report; Sender's Comments: This case concerns a 69-year-old female patient with no previous relevant medical history, who experienced the serious expected event of Anaphylactic reaction after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred minutes after the second dose of Spikevax. Clinical manifestations included Oropharyngeal discomfort, respiratory disorder and Rash. The event resolved after 25 minutes of observation. No medical intervention was reported. The rechallenge is not applicable, since the event was reported exclusively after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report