Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dehydration, Diarrhoea, Influenza like illness, Oropharyngeal discomfort
Clinical narrative: Flu like symptoms; Diarrhea; Dehydrated; Throat closing; Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: Flu shot (reactions to Flu shot). Past adverse reactions to the above products included Adverse event with Flu shot. Concurrent medical conditions included Allergic reaction to excipient.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant) and OROPHARYNGEAL DISCOMFORT (Throat closing). On 26-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydrated). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anaphylactic reaction, at an unspecified dose and frequency. On 25-Feb-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction) and OROPHARYNGEAL DISCOMFORT (Throat closing) had resolved. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. On 05-Mar-2021, DIARRHOEA (Diarrhea) and DEHYDRATION (Dehydrated) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported Throat was closing right away after vaccination. She took Benadryl and next day she was okay. When she was dehydrated and her physician gave her intravenous (IV) fluids. The patient was also given natural remedies. Her physician told her not to get the second shot.  79 Y/O F, with prior allergic reaction to excipients in flu shot, had a serious expected anaphylactic reaction, with oropharyngeal discomfort, influenza like illness, diarrhoea, and dehydration. Onset the same day as first dose mRNA-1273. Events resolved with diphenhydramine. No rechallenge. Reporter causality not provided. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: A 79 Y/O F, with prior allergic reaction to excipients in flu shot, had a serious expected anaphylactic reaction, with oropharyngeal discomfort, influenza like illness, diarrhoea, and dehydration. Onset the same day as first dose mRNA-1273. Events resolved with diphenhydramine. No rechallenge. Reporter causality not provided. Causality possible from temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.