Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site papule, Vaccination site pruritus
Clinical narrative: Osteoporesis in hips; Sleeplessness/Lack of sleep; Injection site papule/Injection site red bump on stomach; Injection site itching/Injection site red bump on stomach with itchiness; Body Ache and Lack of sleep caused more pain; Injection site redness/Injection site red bump on stomach; Fatigue; Fever/Chills; Fever/Chills; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOPOROSIS (Osteoporesis in hips), INSOMNIA (Sleeplessness/Lack of sleep), VACCINATION SITE PAPULE (Injection site papule/Injection site red bump on stomach), VACCINATION SITE PRURITUS (Injection site itching/Injection site red bump on stomach with itchiness) and PAIN (Body Ache and Lack of sleep caused more pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical history was reported.  Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced OSTEOPOROSIS (Osteoporesis in hips), INSOMNIA (Sleeplessness/Lack of sleep), VACCINATION SITE PAPULE (Injection site papule/Injection site red bump on stomach), VACCINATION SITE PRURITUS (Injection site itching/Injection site red bump on stomach with itchiness), PAIN (Body Ache and Lack of sleep caused more pain), VACCINATION SITE ERYTHEMA (Injection site redness/Injection site red bump on stomach), FATIGUE (Fatigue), PYREXIA (Fever/Chills) and CHILLS (Fever/Chills). The patient was treated with DICLOFENAC at an unspecified dose and frequency. At the time of the report, OSTEOPOROSIS (Osteoporesis in hips), INSOMNIA (Sleeplessness/Lack of sleep), VACCINATION SITE PAPULE (Injection site papule/Injection site red bump on stomach), VACCINATION SITE PRURITUS (Injection site itching/Injection site red bump on stomach with itchiness), PAIN (Body Ache and Lack of sleep caused more pain), VACCINATION SITE ERYTHEMA (Injection site redness/Injection site red bump on stomach) and FATIGUE (Fatigue) had not resolved and PYREXIA (Fever/Chills) and CHILLS (Fever/Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that second dose of moderna caused fever/chills, osteoporesis in hips, fatigue, lack of sleep caused more pain, injection site red bump on stomach with itchiness, second dose of moderna caused body ache. The patient was treated with Diclofenac  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-592782 (Patient Link).