Reporte zur Charge 012MZ0A/012M20A

Symptomtext

The syringe separated from the needle and leaked out on my skin, it appears as i wasn't clear if i got the full dose; The syringe separated from the needle and leaked out on my skin; The pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got; I had a little tenderness, no pain; A spontaneous report was received from a physician, a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "PT had a little tenderness, no pain," "the syringe separated from the needle and leaked out on my skin," and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got." The patient's medical history was not provided. No relevant concomitant medications were reported. On 01 Feb 2021, at 13:30, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012MZ0A/012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 01 Feb 2021, during vaccine administration, the syringe separated from the needle and leaked onto the patient's skin. It wasn't clear if the full dose was given. The pharmacist administering the vaccine then tried to give a second dose and the same thing happened both times. The patient was not sure how much he received. No treatment was provided. Action taken with mRNA-1273 in response to the events was not reported. The events of "the syringe separated from the needle and leaked out on my skin", and "the pharmacist who administered the vaccine tried twice in giving the dose and same thing happen both times; don't know how much I got", were considered resolved on 01 Feb 2021. The event outcome of "I had a little tenderness, no pain" was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these event/s has been provided at this time