Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Condition aggravated, Feeding disorder, Gastritis
Clinical narrative: broke her hip; Arthritis/Her joints were so crippled. They were crippled beforehand but now they're even more crippled/Her legs feel useless; Gastritis; esophagitis; She feels like she can't move today; hasn't eaten for two days; chronic pain; Fever; chills; This spontaneous case was reported by a patient and describes the occurrence of HIP FRACTURE (broke her hip) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 303042) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer booster vaccine on 20-Sep-2021, Pfizer booster vaccine on 18-Mar-2022, Pfizer booster vaccine on 04-May-2022 and Pfizer booster vaccine on 17-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer booster vaccine, Pfizer booster vaccine, Pfizer booster vaccine and Pfizer booster vaccine.    On 18-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HIP FRACTURE (broke her hip) (seriousness criterion medically significant), ARTHRITIS (Arthritis/Her joints were so crippled. They were crippled beforehand but now they're even more crippled/Her legs feel useless), GASTRITIS (Gastritis), OESOPHAGITIS (esophagitis), HYPOKINESIA (She feels like she can't move today), FEEDING DISORDER (hasn't eaten for two days), PAIN (chronic pain), PYREXIA (Fever) and CHILLS (chills). The patient was treated with Physical therapy (Broken hips) for Hip fracture. At the time of the report, HIP FRACTURE (broke her hip), ARTHRITIS (Arthritis/Her joints were so crippled. They were crippled beforehand but now they're even more crippled/Her legs feel useless), GASTRITIS (Gastritis), OESOPHAGITIS (esophagitis), HYPOKINESIA (She feels like she can't move today), FEEDING DISORDER (hasn't eaten for two days), PAIN (chronic pain), PYREXIA (Fever) and CHILLS (chills) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient was dying but not really dying. Her reaction was so huge. Her legs felt useless. The pain was remarkable. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning an elderly female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Hip fracture, and the unexpected and non-serious AESI of Arthritis, which occurred on an unknown date after mRNA-1273.815 (SPIKEVAX 2023-2024), administered as seventh dose within COVID-19 vaccination schedule. As reported, patient felt like all the "-itis" in her body, arthritis, gastritis, esophagitis, everything got aggravated. She felt her hip, joints like they all needed to be oiled. She's dying, but not really dying. Her legs feel useless. She's been in physical therapy for a year because she broke her hip. She has chronic pain. No information disclosed about diagnostic tests performed and treatments received. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) is not affected by this report.   This case was linked to MOD-2021-028819 (Patient Link).