Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Periarthritis, SARS-CoV-2 test
Clinical narrative: Frozen shoulder; Tested positive for Covid-19; Dose 1 administered on 13Feb2021 and Dose 2 administered on 09Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder), COVID-19 (Tested positive for Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13Feb2021 and Dose 2 administered on 09Mar2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A, 015M20A and 02E21A) for COVID-19 prophylaxis.     Patient had no allergies.  Acute and Chronic illnesses at the time of vaccination was reported as no.  Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13Feb2021 and Dose 2 administered on 09Mar2021). In August 2021, the patient experienced COVID-19 (Tested positive for Covid-19). On an unknown date, the patient experienced PERIARTHRITIS (Frozen shoulder). At the time of the report, PERIARTHRITIS (Frozen shoulder) had not resolved and COVID-19 (Tested positive for Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 13Feb2021 and Dose 2 administered on 09Mar2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: Positive. In August 2022, SARS-CoV-2 test: Positive.         Other relevant concomitant medications included blood pressure medications, sugar medications and heart medicines.  No treatment information was provided. Company Comment: This spontaneous case concerns a 62-year-old male patient, with no medical history reported, who experienced the unexpected, non-serious event of Periarthritis (reported as FROZEN SHOULDER) which occurred after mRNA-1273 dose administration, which was the patient's 2nd dose of COVID-19 vaccination schedule.  Latency cannot be assessed due to lack of exact event onset date. There was 24 days apart between 1st and 2nd dose of mRNA-1273 vaccination; inappropriate schedule of product administration was also reported in the case. The patient was advised to have next vaccine administered in thigh and 3rd dose of mRNA-1273 was administered this way. It was reported that concomitant medications included unspecified "sugar medications" suggesting presence of diabetes mellitus which could be considered as risk factor for the event. Patient also had COVID-19 test positive approximately 5 months after the 2nd vaccination dose. No further clinical information or details about course of the event and its treatment, concurrent conditions with any accompanying circumstances and specific concomitant medication were provided for medical review. The outcome of the event was not recovered at the time of the report. Additional information has been requested and report will be updated upon receipt of follow up information. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-666412 (Patient Link).; Sender's Comments: This spontaneous case concerns a 62-year-old male patient, with no medical history reported, who experienced the unexpected, non-serious event of Periarthritis (reported as FROZEN SHOULDER) which occurred after mRNA-1273 dose administration, which was the patient's 2nd dose of COVID-19 vaccination schedule.  Latency cannot be assessed due to lack of exact event onset date. There was 24 days apart between 1st and 2nd dose of mRNA-1273 vaccination; inappropriate schedule of product administration was also reported in the case. The patient was advised to have next vaccine administered in thigh and 3rd dose of mRNA-1273 was administered this way. It was reported that concomitant medications included unspecified "sugar medications" suggesting presence of diabetes mellitus which could be considered as risk factor for the event. Patient also had COVID-19 test positive approximately 5 months after the 2nd vaccination dose. No further clinical information or details about course of the event and its treatment, concurrent conditions with any accompanying circumstances and specific concomitant medication were provided for medical review. The outcome of the event was not recovered at the time of the report. Additional information has been requested and report will be updated upon receipt of follow up information. The benefit-risk relationship of mRNA-1273 is not affected by this report.