Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Neuralgia, Pain in extremity, Product storage error, Trigeminal neuralgia
Clinical narrative: Three doses were left out at ambient room temperature past there beyond use date; slight arm pain; nerve pain but does have trigeminal nerve pain; nerve pain but does have trigeminal nerve pain; Three doses were left out at ambient room temperature past there beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (slight arm pain), NEURALGIA (nerve pain but does have trigeminal nerve pain), TRIGEMINAL NEURALGIA (nerve pain but does have trigeminal nerve pain), EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) and PRODUCT STORAGE ERROR (Three doses were left out at ambient room temperature past there beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (slight arm pain), TRIGEMINAL NEURALGIA (nerve pain but does have trigeminal nerve pain) and EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date). 12-Apr-2021, the patient experienced NEURALGIA (nerve pain but does have trigeminal nerve pain). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Three doses were left out at ambient room temperature past there beyond use date). At the time of the report, PAIN IN EXTREMITY (slight arm pain), NEURALGIA (nerve pain but does have trigeminal nerve pain) and TRIGEMINAL NEURALGIA (nerve pain but does have trigeminal nerve pain) had not resolved and EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) and PRODUCT STORAGE ERROR (Three doses were left out at ambient room temperature past there beyond use date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were  reported.  In the recent follow up the patient stated that he feels like he needs to receive a booster dose.  This is a case of expired product administered and product storage error for this 64-year-old male. Regarding events pain in extremity, neuralgia and Trigeminal neuralgia, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.     Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Significant follow up received-Secondary reporter details were included, patient details race, ethnicity, product details include route of administration, anatomical location, details of dose 1 and new events updated, expired vaccine used and product storage error events were updated. On 28-Jul-2021: Significant information received- Events outcome was updated.; Sender's Comments: This is a case of expired product administered and product storage error for this 64-year-old male. Regarding events pain in extremity, neuralgia and Trigeminal neuralgia, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.