Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination site pain
Clinical narrative: Patient had soreness at the injection site; moved the expiration date upto the May 5, 2023, when expiration date from Moderna is June 18,2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient had soreness at the injection site) and EXPIRED PRODUCT ADMINISTERED (moved the expiration date upto the May 5, 2023, when expiration date from Moderna is June 18,2022) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 069H22A and AS7163B) for COVID-19 prophylaxis.     Concurrent medical conditions included Disease Crohns (Crohns Disease since age 20 years before the patients first dose of the Moderna covid-19 vaccine.).   On 23-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (moved the expiration date upto the May 5, 2023, when expiration date from Moderna is June 18,2022). On an unknown date, the patient experienced VACCINATION SITE PAIN (Patient had soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Patient had soreness at the injection site) and EXPIRED PRODUCT ADMINISTERED (moved the expiration date upto the May 5, 2023, when expiration date from Moderna is June 18,2022) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient received Moderna bivalent vaccine on the week of April 17 to April 21 lot number 069H22A expiration date was May 5, 2023. The patient was upset that she received a vaccine so close to the expiration date. The patient was concerned that the administration of the vaccine was so close to the expiration date. The patient also stated that the actual lot number of the Moderna Covid-19 vaccine expires in June.   The patient received the first Moderna Covid 19 vaccine on January 9, 2021 lot number 026L20A expiration date was not available. Patient received the vaccine in left arm. The patient reported soreness of her left arm. The patient was dizzy, redness in her left arm, injection site warm to feel of touch and the patient felt lightheaded.  The patient received the second Moderna Covid-19 vaccine in February 6, 2023 lot number 013L20A expiration date was not known. Patient received the vaccine in left arm. The patient reported soreness and a bump at the injection site. Injection site was red and raised, soreness of her left arm and the patient was dizzy along with the left arm injection site had redness, and was warm to feel of touch. The patient was lightheaded.  The patient received the third Moderna Covid-19 vaccine as a Monovalent booster dose on August 17, 2021 lot 003C21A and no expiration date. Patient received in left arm. Redness and soreness at the injection site along with soreness of the left arm. The patient was dizzy and the left arm injection site was warm to feel of touch. The patient felt lightheaded.  The patient reported that she received the fourth Moderna Monovalent vaccine on March 20, 2022 lot number 072J21A the lot number might be 042J21A expiration date was not known. Patient received the vaccine in left arm. Patient had redness and soreness at the injection site. The injection site was warm at the injection site.   No treatment medication information was reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-721469 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live Follow up Information was received. On 25-Apr-2023: Live significant follow up information as received_Suspect product vaccine (additional dosage regimen- first Moderna Bivalent booster vaccine, expiry date), Medical history and Additional events was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721469:(Monovalent Dose)