Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: SARS-CoV-2 test, Vaccination site induration, Vaccination site swelling
Clinical narrative: Pelvic lift surgery; General body pain/body aches; Vaccination site swelling/ Covid vaccine issue/arm was swollen and Hardened at the injection site; Vaccination site induration/Covid vaccine issue/arm was swollen and hardened at the injection site; COVID-19; Feelings of weakness/Felt weak; Feeling hot and cold/ Hot and cold flashes; This spontaneous case was reported by a consumer and describes the occurrence of PELVIC OPERATION (Pelvic lift surgery) in a 45-year-old 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 information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 07-Jul-2022, the patient experienced COVID-19 (COVID-19). In July 2022, the patient experienced ASTHENIA (Feelings of weakness/Felt weak) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold/ Hot and cold flashes). On an unknown date, the patient experienced PELVIC OPERATION (Pelvic lift surgery) (seriousness criterion medically significant), PAIN (General body pain/body aches), VACCINATION SITE SWELLING (Vaccination site swelling/ Covid vaccine issue/arm was swollen and Hardened at the injection site) and VACCINATION SITE INDURATION (Vaccination site induration/Covid vaccine issue/arm was swollen and hardened at the injection site). On 21-Jul-2022, COVID-19 (COVID-19) had resolved. At the time of the report, PELVIC OPERATION (Pelvic lift surgery), PAIN (General body pain/body aches), VACCINATION SITE SWELLING (Vaccination site swelling/ Covid vaccine issue/arm was swollen and Hardened at the injection site) and VACCINATION SITE INDURATION (Vaccination site induration/Covid vaccine issue/arm was swollen and hardened at the injection site) outcome was unknown and ASTHENIA (Feelings of weakness/Felt weak) and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold/ Hot and cold flashes) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2022, SARS-CoV-2 test: (Positive) Positive. On 21-Jul-2022, SARS-CoV-2 test: (Negative) Negative.         Concomitant medication was not provided. The symptoms of COVID-19 improved after one week, but it took 2 weeks for the test to come back negative. Patient was advised to hold Humira dose until she was better. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. For HUMIRA, reporter causality was given as not reported and MAH causality as no reasonable possibility. Treatment information was not reported.  Company Comment: This is a spontaneous case concerning  a  45-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Pelvic operation and unexpected non-serious events of COVID-19, Asthenia, Feeling of body temperature change, Pain and expected non-serious events of Vaccination site swelling, Vaccination site induration. The exact date of administration of first, second, third dose of mRNA-1273 vaccine, was not specified, hence latency could not be assessed.  The Co-suspect drug of Adalimumab was also administered on an unknown date. Patient tested initially positive and then turned negative for SARS COV-2.  No further details on clinical course, other laboratory test results and treatment received were reported. At the time of the report, Pelvic operation, Pain, Vaccination site swelling, Vaccination site induration outcome was unknown and Asthenia, Feeling of body temperature change had resolved. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. Event terms, seriousness criteria and product information were captured as provided.; Sender's Comments: This is a spontaneous case concerning  a  45-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Pelvic operation and unexpected non-serious events of COVID-19, Asthenia, Feeling of body temperature change, Pain and expected non-serious events of Vaccination site swelling, Vaccination site induration. The exact date of administration of first, second, third dose of mRNA-1273 vaccine, was not specified, hence latency could not be assessed.  The Co-suspect drug of Adalimumab was also administered on an unknown date. Patient tested initially positive and then turned negative for SARS COV-2.  No further details on clinical course, other laboratory test results and treatment received were reported. At the time of the report, Pelvic operation, Pain, Vaccination site swelling, Vaccination site induration outcome was unknown and Asthenia, Feeling of body temperature change had resolved. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report. Event terms, seriousness criteria and product information were captured as provided.