Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pruritus, Pyrexia
Clinical narrative: Itchy in both arms; Both arms are itchy; Severe nerve pain in lower legs.; Allergist administered vaccine in 2 parts (1/2 in one arm followed 30 minutes later by the other 1/2; Severe nerve pain in both wrists; nausea; chills; fever; head felt like a lump of concrete; A spontaneous report was received from a Consumer concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events has a hard time getting up at night, nausea, itchy in both arms, chills, fever, slept for hours, head felt like a lump of concrete, both arms are itchy, severe nerve pain in both wrists, severe nerve pain in lower legs., allergist administered vaccine in 2 parts (1/ 2 in one arm followed 30 minutes later by the other 1/ 2 in opposite arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 022M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced the event(s) has a hard time getting up at night . On 19 Feb 2021, the patient experienced the event(s) nausea . On 23 Feb 2021, the patient experienced the event(s) itchy in both arms . On 19 Feb 2021, the patient experienced the event(s) chills . On 19 Feb 2021, the patient experienced the event(s) fever . On 19 Feb 2021, the patient experienced the event(s) slept for hours . On 19 Feb 2021, the patient experienced the event(s) head felt like a lump of concrete . On 19 Feb 2021, the patient experienced the event(s) both arms were itchy . On 19 Feb 2021, the patient experienced the event(s) severe nerve pain in both wrists . On 19 Feb 2021, the patient experienced the event(s) severe nerve pain in lower legs. . On 19 Feb 2021, the patient experienced the event(s) allergist administered vaccine in 2 parts (1 2 in one arm followed 30 minutes later by the other 1/ 2.in the opposite arm. On 20 Feb 2021 patient felt much worse and has a hard time getting up at night. On 23 Feb 2021, she felt like they were approaching normal, but both arms were itchy.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), has a hard time getting up at night was unknown.The outcome of event(s), nausea was unknown.The outcome of event(s), itchy in both arms was unknown.The outcome of event(s), chills was unknown.The outcome of event(s), fever was unknown.The outcome of event(s), slept for hours was unknown.The outcome of event(s), head felt like a lump of concrete was unknown.The outcome of event(s), both arms are itchy was unknown.The outcome of event(s), severe nerve pain in both wrists was unknown.The outcome of event(s), severe nerve pain in lower legs. was unknown.The outcome of event(s), allergist administered vaccine in 2 parts (1 2 in one arm followed 30 minutes later by the other 1 2 was 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. The causality for the event Vaccine administered at inappropriate site is assessed as Not Applicable.