Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Nodule, Paraesthesia, Skin burning sensation, Skin discolouration
Clinical narrative: the nodules have grown 2x bigger since the last time she called; it felt like something twisted in multiple places in my body; she woke up multiple times; a lot more bruises and odd coloration; my whole body inflamed; bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck; make-up covers a great deal of redness on my face; nodule on Rt ankle appears; Right side body & arm tingling; Swelling of hands and feet (angioedema); Full-body Hives; Hot flashes; Burning sensation on her back; A spontaneous report was received from a consumer  concerning a 50-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Full-body Hives,Hot flashes,Burning sensation on her back,Swelling of hands and feet (angioedema), Right side body & arm tingling,the nodules have grown 2x bigger since the last time she called,bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck,she woke up multiple times,it felt like something twisted in multiple places in my body,whole body inflamed, have seen a lot of mirroring on my body. and lot more bruises and odd coloration.  The patient's medical history, was not provided.No Concomitant medications were  reported .  On 03 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029A21A) intramuscularly in the right deltoid  for prophylaxis of COVID-19 infection.   On 03 Mar 2021  , prior to receiving mRNA-1273, the patient felt Full-body Hives,Hot flashes,Burning sensation on her back,Swelling of hands and feet (angioedema), hands,feet ,legs and arms swelling and on 04 Mar 2021 Right side body & arm tingling.  A follow up was done on 12 Mar 2021  and  reported events , on 11 Mar 2021 growth  on ankle appears and on 12 Mar 2021 whole body inflamed, bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck and on 16 Mar 2021 have seen a lot of mirroring on my body. and lot more bruises and odd coloration and on an unknown date the nodules have grown 2x bigger since the last time she called, and on 18 Jan 2021 she woke up multiple times, felt like something twisted in multiple places in my body and angioedema was medically significant.   A second follow up was also done on 19 Mar 2021.  Treatment for the events included Corticosteroid injection , Benadryl 300mg , xyzal, montelukast, Zyrtec,Oral prednisone,pepcid AC Epi-pen (not used).  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Full-body Hives,Hot flashes,Burning sensation on her back,Swelling of hands and feet (angioedema), Right side body & arm tingling was not recovered and the outcome of the events the nodules have grown 2x bigger since the last time she called,bruising all over arms, legs, ankles, under elbow and on both hands/bruises on neck,she woke up multiple times,it felt like something twisted in multiple places in my body,whole body inflamed,growth  on ankle appears,hands,feet ,legs and arms swelling,have seen a lot of mirroring on my body. and lot more bruises and odd coloration was unknown.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded.