Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain in extremity, Ultrasound scan
Clinical narrative: I have tight muscles up the front of my legs; The Muscles in my legs keep cramping.; It's turning me into a cripple.; I started having pain in my arms/My arms hurt.; I started having pain in the joint of my left hip; interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of DISABILITY (It's turning me into a cripple.) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: J & J Covid-19 vaccine (1st Dose) on 12-Mar-2021 and J & J Covid-19 vaccine (Booster Dose) on 08-Dec-2021. Past adverse reactions to the above products included No adverse event with J & J Covid-19 vaccine and J & J Covid-19 vaccine.    On 24-Oct-2022, 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 24-Oct-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On 28-Oct-2022, the patient experienced ARTHRALGIA (I started having pain in the joint of my left hip). On 21-Nov-2022, the patient experienced PAIN IN EXTREMITY (I started having pain in my arms/My arms hurt.). On 22-Nov-2022, the patient experienced DISABILITY (It's turning me into a cripple.) (seriousness criterion medically significant), MUSCLE TIGHTNESS (I have tight muscles up the front of my legs) and MUSCLE SPASMS (The Muscles in my legs keep cramping.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 22-Nov-2022 at a dose of 2 Pills, q4h and LIDOCAINE (ASPERCREME LIDOCAINE PATCH) at an unspecified dose and frequency. At the time of the report, DISABILITY (It's turning me into a cripple.), PAIN IN EXTREMITY (I started having pain in my arms/My arms hurt.), MUSCLE TIGHTNESS (I have tight muscles up the front of my legs), MUSCLE SPASMS (The Muscles in my legs keep cramping.), ARTHRALGIA (I started having pain in the joint of my left hip), INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2022, Ultrasound scan: There were no blood clots found.     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 medications were reported. The physician confirmed the patient might had pulled a muscle in hip. Treatment included Salonpas patches. Company comment: This spontaneous case concerns a 74-years-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Disability that occurred 30 days after the third dose of mRNA-1273 bivalent BA.4/BA.5 vaccination. Patient also experienced non-serious events of Arthralgia, Pain in extremity, Muscle tightness and Muscle spasms. The events outcome was reported as unknown. It was reported that physician confirmed that patient might have pulled a muscle in hip. The patient was treated with IBUPROFEN and LIDOCAINE. No further information regarding clinical course, concomitant medication and other treatment details were provided. The patient received the previous doses of J & J Covid-19 vaccine the last dose being given about 11 months prior to the current vaccine, with no reported adverse events. Thus, an interchange of vaccine products and COVID-19 immunization (Revaccination with different COVID-19 vaccine) were also noted in the case. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report. Event was assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 74-years-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Disability that occurred 30 days after the third dose of mRNA-1273 bivalent BA.4/BA.5 vaccination. Patient also experienced non-serious events of Arthralgia, Pain in extremity, Muscle tightness and Muscle spasms. The events outcome was reported as unknown. It was reported that physician confirmed that patient might have pulled a muscle in hip. The patient was treated with IBUPROFEN and LIDOCAINE. No further information regarding clinical course, concomitant medication and other treatment details were provided. The patient received the previous doses of J & J Covid-19 vaccine the last dose being given about 11 months prior to the current vaccine, with no reported adverse events. Thus, an interchange of vaccine products and COVID-19 immunization (Revaccination with different COVID-19 vaccine) were also noted in the case. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report. Event was assessed as serious based on medical judgement.