Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, Fall, Incorrect route of product administration, No adverse event
Clinical narrative: No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.; 5th dose (bivalent) - 10-Oct-2022, lot number - 053D22A, 6th dose (bivalent) on 17-May-2023, lot number - AS7172B; No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.; she fell out of bed on 02-Mar-2023; This spontaneous case was reported by a patient and describes the occurrence of FALL (she fell out of bed on 02-Mar-2023), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.), EXTRA DOSE ADMINISTERED (5th dose (bivalent) - 10-Oct-2022, lot number - 053D22A, 6th dose (bivalent) on 17-May-2023, lot number - AS7172B) and NO ADVERSE EVENT (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 053D22A and AS7172B) for COVID-19 prophylaxis.     The patient's past medical history included Magnesium deficiency and Whooping cough. Previously administered products included for Product used for unknown indication: TETANUS VACCINE. Past adverse reactions to the above products included No adverse event with TETANUS VACCINE. Concurrent medical conditions included Raynaud's disease (Lupus spectrum), Fibromyalgia, Diabetes, Hypertension, Hypothyroidism (The patient was on Synthroid.) and Gene mutation (The patient has a gene mutation which predisposes her to blood clots (prothrombin II).). Concomitant products included PREDNISOLONE for an unknown indication.   On 10-Oct-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) 1 dosage form. On 17-May-2023, received sixth 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 02-Mar-2023, the patient experienced FALL (she fell out of bed on 02-Mar-2023). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.), EXTRA DOSE ADMINISTERED (5th dose (bivalent) - 10-Oct-2022, lot number - 053D22A, 6th dose (bivalent) on 17-May-2023, lot number - AS7172B) and NO ADVERSE EVENT (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.). At the time of the report, FALL (she fell out of bed on 02-Mar-2023) was resolving and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.), EXTRA DOSE ADMINISTERED (5th dose (bivalent) - 10-Oct-2022, lot number - 053D22A, 6th dose (bivalent) on 17-May-2023, lot number - AS7172B) and NO ADVERSE EVENT (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.) to be not related. No further causality assessments were provided for FALL (she fell out of bed on 02-Mar-2023), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (No side effects - Had 3rd booster - Administered in the inner fatty part of upper shoulder.) and EXTRA DOSE ADMINISTERED (5th dose (bivalent) - 10-Oct-2022, lot number - 053D22A, 6th dose (bivalent) on 17-May-2023, lot number - AS7172B).    It was reported that the patient was over 65 years old and has 3 autoimmune diseases (Raynaud's disease, fibromyalgia, and diabetes). The patient received Moderna Monovalent vaccines as Dose 1 on 09-Mar-2021 with lot number - 036A21A, Dose 2 on 06-Apr-2021 with lot number - 036A21A, Dose 3 on 05-May-2021 with lot number 017F21A and Dose 4 on 01-Jun-2022 with lot number - 037A22A. On 02-Mar-2023, the patient fell out of bed. The patient received prednisolone 4 mg for 6 days. It was reported that the patient had her 6th dose (Second bivalent) on 17-May-2023 and it was administered on the inner fatty part of her upper shoulder.  Treatment information was not provided.   This case was linked to MOD-2023-725295 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Significant follow-up appended: New event added and narrative updated. On 19-May-2023: Live Significant follow-up appended: Patient details updated, Medical History updated, Suspect product details updated and case narrative updated.