Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Oesophagitis, Pain in extremity, Weight, Weight decreased
Clinical narrative: patient had extreme lower back pain , was hospitalized in APR-2021 because of the extreme pain; leg pain/extreme pain; esophageal inflammation; an extreme pain when she swallowed; individual lost 20 pounds; she couldn't eat; individual had pain in the hip, leg, calf, and ankle; couldn't sleep for nights; individual could barely move; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (patient had extreme lower back pain , was hospitalized in APR-2021 because of the extreme pain) and PAIN IN EXTREMITY (leg pain/extreme pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced BACK PAIN (patient had extreme lower back pain , was hospitalized in APR-2021 because of the extreme pain) (seriousness criterion hospitalization). In 2021, the patient experienced PAIN IN EXTREMITY (leg pain/extreme pain) (seriousness criterion hospitalization), INSOMNIA (couldn't sleep for nights) and HYPOKINESIA (individual could barely move). In November 2021, the patient experienced ARTHRALGIA (individual had pain in the hip, leg, calf, and ankle). On an unknown date, the patient experienced OESOPHAGITIS (esophageal inflammation), DYSPHAGIA (an extreme pain when she swallowed), WEIGHT DECREASED (individual lost 20 pounds) and FEEDING DISORDER (she couldn't eat). The patient was hospitalized on sometime in April 2021 due to BACK PAIN and PAIN IN EXTREMITY. The patient was treated with MORPHINE for Leg pain, at an unspecified dose and frequency. In 2021, BACK PAIN (patient had extreme lower back pain , was hospitalized in APR-2021 because of the extreme pain) had resolved. In July 2022, ARTHRALGIA (individual had pain in the hip, leg, calf, and ankle) had resolved. At the time of the report, PAIN IN EXTREMITY (leg pain/extreme pain), INSOMNIA (couldn't sleep for nights), HYPOKINESIA (individual could barely move), OESOPHAGITIS (esophageal inflammation), DYSPHAGIA (an extreme pain when she swallowed), WEIGHT DECREASED (individual lost 20 pounds) and FEEDING DISORDER (she couldn't eat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost 20 pounds.         Concomitant product use was not provided by the reporter.   It was reported that the patient started treatment on an unspecified day in Mar-2021 with Moderna COVID-19 vaccine dose 2 and on an unspecified day in Nov-2021 with dose 3 (reported as first booster) for COVID-19 immunisation. It was reported the patient had extreme lower back pain after the second shot in Mar-2021, after which she had to go through physical therapy and it went away after 4 months. The patient was hospitalized in Apr-2021 because of the extreme pain and had leg pain and treated with morphine. The patient could not sleep for nights. After the first booster in Nov-2021, the individual had pain in the hip, leg, calf, and ankle, the individual could barely move. In Jul-2022, 8 months later, the pain wore off. Then the individual had esophageal inflammation and an extreme pain when she swallowed. The individual lost 20 pounds because she could not eat. At the time of reporting, the individual was doing great.  Company Comment :This is a spontaneous case concerning a 72-year-old female patient, with no medical history reported, who experienced the serious (hospitalization) events of back pain and pain in extremity, which occurred around the same month after the second dose of mRNA-1273 was administered. It was reported that the patient had extreme lower back pain after the second dose, which had improved through physical therapy after four months. On the next month, she was hospitalized because of the extreme pain and had leg pain and was treated with Morphine. She could not sleep for nights. The patient received the first booster dose of mRNA-1273 almost eight months later. After that, the patient had pain in the hip, leg, calf and ankle, so she could barely move. Eight months later, the pain wore off. Then, she had esophageal inflammation and an extreme pain when she swallowed. Since the patient could not eat, she lost 20 pounds. At the time of the last observation, the events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient, with no medical history reported, who experienced the serious (hospitalization) events of back pain and pain in extremity, which occurred around the same month after the second dose of mRNA-1273 was administered. It was reported that the patient had extreme lower back pain after the second dose, which had improved through physical therapy after four months. On the next month, she was hospitalized because of the extreme pain and had leg pain and was treated with Morphine. She could not sleep for nights. The patient received the first booster dose of mRNA-1273 almost eight months later. After that, the patient had pain in the hip, leg, calf and ankle, so she could barely move. Eight months later, the pain wore off. Then, she had esophageal inflammation and an extreme pain when she swallowed. Since the patient could not eat, she lost 20 pounds. At the time of the last observation, the events had resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.