Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity, Swelling
Clinical narrative: sore arm; swelling; armpit pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), SWELLING (swelling) and AXILLARY PAIN (armpit pain) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   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 PAIN IN EXTREMITY (sore arm), SWELLING (swelling) and AXILLARY PAIN (armpit pain). At the time of the report, PAIN IN EXTREMITY (sore arm), SWELLING (swelling) and AXILLARY PAIN (armpit pain) outcome was unknown.            Treatment product was not provided by the reporter.  Company comment: This case concerns a 21-year-old female patient with no medical history provided, who experienced the unexpected non-serious events of Pain in extremity and Swelling (the exact localization of the event was not provided), as well as non-serious expected event of Axillary pain. The event occurred following the administration of the second dose of the mRNA-1273 vaccine, however, the exact temporal relationship cannot be determined as the date of vaccination and start date of the events were not disclosed. The patient experienced the same events after the vaccination with the first dose, as well as after the vaccination after the third (booster dose), however, as the outcome of the events after the second dose was not specified and remained unknown, the re-challenge is not applicable (re-challenge will be re-assessed after follow up information is received). No further information regarding the clinical course of the events was provided at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405397, MOD-2021-017910 (Patient Link).; Sender's Comments: This case concerns a 21-year-old female patient with no medical history provided, who experienced the unexpected non-serious events of Pain in extremity and Swelling (the exact localization of the event was not provided), as well as non-serious expected event of Axillary pain. The event occurred following the administration of the second dose of the mRNA-1273 vaccine, however, the exact temporal relationship cannot be determined as the date of vaccination and start date of the events were not disclosed. The patient experienced the same events after the vaccination with the first dose, as well as after the vaccination after the third (booster dose), however, as the outcome of the events after the second dose was not specified and remained unknown, the re-challenge is not applicable (re-challenge will be re-assessed after follow up information is received). No further information regarding the clinical course of the events was provided at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.