Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: received booster dose from expired vial; very itchy, bump on site going down; Redness on inside of arm where shot was given; very itchy, bump on site going down; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE INDURATION (very itchy, bump on site going down), VACCINATION SITE ERYTHEMA (Redness on inside of arm where shot was given), VACCINATION SITE PRURITUS (very itchy, bump on site going down) and EXPIRED PRODUCT ADMINISTERED (received booster dose from expired vial) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza (influenza high dose vaccine Sanofi Pasteur). Concurrent medical conditions included Egg allergy, Shellfish allergy, Fruit allergy (Strawberry allergy), Depression, Anxiety, Hypertension and High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LISINOPRIL for Hypertension, VITAMIN D NOS for an unknown indication.    On 29-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In 2021, the patient experienced VACCINATION SITE INDURATION (very itchy, bump on site going down), VACCINATION SITE ERYTHEMA (Redness on inside of arm where shot was given) and VACCINATION SITE PRURITUS (very itchy, bump on site going down). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster dose from expired vial). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received booster dose from expired vial) had resolved. At the time of the report, VACCINATION SITE INDURATION (very itchy, bump on site going down), VACCINATION SITE ERYTHEMA (Redness on inside of arm where shot was given) and VACCINATION SITE PRURITUS (very itchy, bump on site going down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  This is a case of expired product administered concerning a 70-year-old, female patient, with no relevant medical history, who experienced the non-serious expected events of vaccination site induration, vaccination site erythema and vaccination site pruritus. The events occurred  on the same day after the third dose of Moderna vaccine. The rechallenge is not applicable as another dose is not expected. The benefit-risk relationship of Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: follow up received contains updated reporter type, patient demographic details, medical history, added concomitant medications and added events; Sender's Comments: This is a case of expired product administered concerning a 70-year-old, female patient, with no relevant medical history, who experienced the non-serious expected events of vaccination site induration, vaccination site erythema and vaccination site pruritus. The events occurred  on the same day after the third dose of Moderna vaccine. The rechallenge is not applicable as another dose is not expected. The benefit-risk relationship of Moderna vaccine is not affected by this report.