Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal swelling
Clinical narrative: Anaphylactic reaction after first vaccine and  post Amoxicillin/allergic reaction; Swelling in throat after first vaccine and post Amoxicillin; Could not breath after first vaccine & post Amoxicillin; This spontaneous case was reported by a pharmacist and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction after first vaccine and  post Amoxicillin/allergic reaction), PHARYNGEAL SWELLING (Swelling in throat after first vaccine and post Amoxicillin) and DYSPNOEA (Could not breath after first vaccine & post Amoxicillin) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.    Co-suspect product included non-company product AMOXICILLIN for Tooth infection.    Previously administered products included for Tooth infection: Amoxicillin from 23-Dec-2021 to 31-Dec-2021. Past adverse reactions to the above products included No adverse event with Amoxicillin. Concurrent medical conditions included Tooth infection.   On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient started AMOXICILLIN (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction after first vaccine and  post Amoxicillin/allergic reaction) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Swelling in throat after first vaccine and post Amoxicillin) (seriousness criterion medically significant) and DYSPNOEA (Could not breath after first vaccine & post Amoxicillin) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction after first vaccine and  post Amoxicillin/allergic reaction), PHARYNGEAL SWELLING (Swelling in throat after first vaccine and post Amoxicillin) and DYSPNOEA (Could not breath after first vaccine & post Amoxicillin) outcome was unknown.        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.   Concomitant Medication use information was not provided by reporter.  On 18J AN 2022 restarted Amoxicillin for tooth infection again and ended up in the hospital with an allergic reaction. Patient thought that she had developed allergy to Amoxicillin and having anaphylactic reaction to amoxicillin.  Treatment Medication use information was not provided by reporter.  Company comment: This is a spontaneous case concerning a 57-year-old, female patient with concomitant medication of Amoxicillin, who experienced the unexpected serious events of pharyngeal swelling and dyspnea and expected serious event of anaphylactic reaction. The events anaphylactic reaction, pharyngeal swelling and dyspnea occurred 12 days after the first dose of mRNA-1273 vaccine administration. The events were described as, the patient received Amoxicillin treatment for approximately one week for tooth infection with the last dose of 6 days prior to the first dose of mRNA-1273 vaccine administration. 12 days after the first dose of mRNA-1273 vaccine administration, patient restarted with Amoxicillin for the same indication and the within the same day patient experienced throat swelling and could not breath and ended up in the hospital. No reported treatment information. The outcome of the events anaphylactic reaction, pharyngeal swelling and dyspnea were unknown. The concomitant medication of Amoxicillin remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Seriousness criteria updated for event Anaphylactic reaction.; Sender's Comments: This is a spontaneous case concerning a 57-year-old, female patient with concomitant medication of Amoxicillin, who experienced the unexpected serious events of pharyngeal swelling and dyspnea and expected serious event of anaphylactic reaction. The events anaphylactic reaction, pharyngeal swelling and dyspnea occurred 12 days after the first dose of mRNA-1273 vaccine administration. The events were described as, the patient received Amoxicillin treatment for approximately one week for tooth infection with the last dose of 6 days prior to the first dose of mRNA-1273 vaccine administration. 12 days after the first dose of mRNA-1273 vaccine administration, patient restarted with Amoxicillin for the same indication and the within the same day patient experienced throat swelling and could not breath and ended up in the hospital. No reported treatment information. The outcome of the events anaphylactic reaction, pharyngeal swelling and dyspnea were unknown. The concomitant medication of Amoxicillin remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.