Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Spikevax 2023-2024 Pre-filled syringe 0.5ml which was already past beyond use date of 09FEB2024.; she is experiencing pain in her right arm. Pain starts right below her shoulder and extends to her wrist.; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (she is experiencing pain in her right arm. Pain starts right below her shoulder and extends to her wrist.) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031048) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine (Dose 3); for Product used for unknown indication: Pfizer vaccine (Dose 2) and Pfizer vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Moderna covid-19 vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Diabetes. Concomitant products included RSV VACCINE from 16-Feb-2024 to 16-Feb-2024 for an unknown indication.    On 16-Feb-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. In February 2024, the patient experienced PAIN IN EXTREMITY (she is experiencing pain in her right arm. Pain starts right below her shoulder and extends to her wrist.) (seriousness criterion medically significant). On 16-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced EXPIRED PRODUCT ADMINISTERED (Spikevax 2023-2024 Pre-filled syringe 0.5ml which was already past beyond use date of 09FEB2024.). At the time of the report, PAIN IN EXTREMITY (she is experiencing pain in her right arm. Pain starts right below her shoulder and extends to her wrist.) had not resolved and EXPIRED PRODUCT ADMINISTERED (Spikevax 2023-2024 Pre-filled syringe 0.5ml which was already past beyond use date of 09FEB2024.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had no history of allergy. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Dosage text for suspect product was reported as unknown. There was no untoward effect that happened to the patient from the time it was given until she left. Patient reported that the pain was not burning, nor shooting and it comes and goes and there was no swelling. The treatment medication was not reported by reporter.  Company comment-This is a spontaneous case concerning a 60-year-old female patient, who received RSV vaccine the same day SPIKEVAX 2023-2024 vaccine was given, who experienced the unexpected serious (medically significant) event pain in extremity. A dose of SPIKEVAX 2023-2024 vaccine, was administered. Exact onset date of the event was not reported hence latency cannot be assessed. Additionally, expired product administered (vaccine given was already past beyond use date) was also reported. Previously the patient received 2 doses of TOZINAMERAN vaccine and a dose of Moderna COVID-19 vaccine. It was reported patient was experiencing pain in her right arm. Pain started right below her shoulder and extended to her wrist. Concomitant administration of RSV vaccine remains as a confounder. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2024: Follow-up has significant information which included updating the reporter details, addition of new event Pain in extremity, updating  i-narrative and new reference number has been added.