Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Urticaria
Clinical narrative: Can't lift arm , hard to do anything with it , lift it a little way; Doctor called it a frozen shoulder; broke out in hives on chest; heart racing; excessive lethargic; was working out everyday and now lays in bed every night; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can't lift arm , hard to do anything with it , lift it a little way), PERIARTHRITIS (Doctor called it a frozen shoulder), URTICARIA (broke out in hives on chest), PALPITATIONS (heart racing) and LETHARGY (excessive lethargic) 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.     Concurrent medical conditions included Lactose intolerance (sensitivities to lactose intolerant). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can't lift arm , hard to do anything with it , lift it a little way), PERIARTHRITIS (Doctor called it a frozen shoulder), URTICARIA (broke out in hives on chest), PALPITATIONS (heart racing), LETHARGY (excessive lethargic) and DECREASED ACTIVITY (was working out everyday and now lays in bed every night). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can't lift arm , hard to do anything with it , lift it a little way), PERIARTHRITIS (Doctor called it a frozen shoulder), URTICARIA (broke out in hives on chest), PALPITATIONS (heart racing), LETHARGY (excessive lethargic) and DECREASED ACTIVITY (was working out everyday and now lays in bed every night) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Regarding the medical history, the patient stated that she believed she had a weak immune system because she got sick easily, however no additional details regarding medical history were not provided.  Patient stated that she had no shoulder injury.  Company comment:  This case concerns a 45-year-old female patient with no relevant medical history, who experienced non serious unexpected events of Urticaria, Periarthritis, Injected limb mobility decreased and decreased activity. The events occurred after the patient had received the third dose of the mRNA-1273 vaccine, however, the exact start dates were not provided, therefore, the precise temporal relationship cannot be determined. According to the information provided, the patient could not lift her arm, and it was hard for her to do regular activities. It was stated that the patient's doctor called the reaction as frozen shoulder. The patient also developed hives on chest and took Benadryl and Allegra as treatment medications. The patient had heart racing and felt excessive lethargic. The patient had been working out everyday, however, after vaccination she stayed in bed every night. It was confirmed that the patient did not have shoulder injury. The outcome of the reported events was unknown at the time of this report. The rechallenge is not applicable as the events occurred after third vaccination. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-478170.; Sender's Comments: This case concerns a 45-year-old female patient with no relevant medical history, who experienced non serious unexpected events of Urticaria, Periarthritis, Injected limb mobility decreased and decreased activity. The events occurred after the patient had received the third dose of the mRNA-1273 vaccine, however, the exact start dates were not provided, therefore, the precise temporal relationship cannot be determined. According to the information provided, the patient could not lift her arm, and it was hard for her to do regular activities. It was stated that the patient's doctor called the reaction as frozen shoulder. The patient also developed hives on chest and took Benadryl and Allegra as treatment medications. The patient had heart racing and felt excessive lethargic. The patient had been working out everyday, however, after vaccination she stayed in bed every night. It was confirmed that the patient did not have shoulder injury. The outcome of the reported events was unknown at the time of this report. The rechallenge is not applicable as the events occurred after third vaccination. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.