Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis, Malaise, Pyrexia
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of CELLULITIS (cellulitis/ today in a lot of discomfort), INJECTION SITE CELLULITIS (Cellulitis at injection site), MALAISE (Feeling unwell/feeling sick), CHILLS (chills) and PYREXIA (highest temperature was 100/) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 012L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Phlebotomy (x3). Previously administered products included for Product used for unknown indication: Hepatitis A. Past adverse reactions to the above products included No adverse event with Hepatitis A. Concurrent medical conditions included Graves' disease since 05-Oct-2010, Haemochromatosis since 2021, Cirrhosis liver (phlebotomy) since 2021, Drug allergy (dilaudid), Drug allergy (rocephin), Drug allergy (E-mycin), Drug allergy (ciprofloxin), Insomnia and Vitamin D deficiency. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) and THYROID (ARMOUR THYROID) for Graves' disease, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, ASCORBIC ACID, COLLAGEN BOVINE, HYALURONATE SODIUM (VITAL PROTEINS ORIGINAL COLLAGEN PEPTIDES WITH HYALURONIC ACID + VITAMIN C) for Supplementation therapy, COLECALCIFEROL (VITAMIN D 3) for Vitamin D deficiency, INFLUENZA VACCINE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced INJECTION SITE CELLULITIS (Cellulitis at injection site), MALAISE (Feeling unwell/feeling sick) and PYREXIA (highest temperature was 100/). On 05-Nov-2021, the patient experienced CHILLS (chills). On 08-Nov-2021, the patient experienced CELLULITIS (cellulitis/ today in a lot of discomfort). The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) on 08-Nov-2021 for Cellulitis and Injection site cellulitis, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 15-Nov-2021, CELLULITIS (cellulitis/ today in a lot of discomfort) and INJECTION SITE CELLULITIS (Cellulitis at injection site) had resolved. At the time of the report, MALAISE (Feeling unwell/feeling sick), CHILLS (chills) and PYREXIA (highest temperature was 100/) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, Body temperature: high (High) Highest temperature was 100.. On 08-Nov-2021, Blood test: normal (normal) normal. On 08-Nov-2021, Computerised tomogram: abnormal (abnormal) cellulitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INJECTION SITE CELLULITIS (Cellulitis at injection site) to be possibly related. No further causality assessments were provided for CELLULITIS (cellulitis/ today in a lot of discomfort), MALAISE (Feeling unwell/feeling sick), CHILLS (chills) and PYREXIA (highest temperature was 100/).    Patient seen was trailing on the blood vessel into her belly button,It was discolored and discomfort around the belly button. Patient had a lot of discomfort , redness started to be around umbilicus .  Company's comment: This spontaneous case concerns a 56-year-old female patient with medical history of Graves' disease since, Haemochromatosis and Cirrhosis in liver, who experienced the unexpected non serious event of Cellulitis associated with injection site cellulitis. The event occurred between 1 and 5 days after receiving the third dose of mRNA-1273 Vaccine. Patient received the vaccine , all three doses, in the left gluteus and she developed pyrexia, chills and injection site inflammation which spread into her abdomen and was diagnosed as a Cellulitis. Received treatment with amoxicillin and was resolved 8 days later. The rechallenge was not applicable since only information about the third dose was disclosed.  The patients past medical history of immunocompromised  in relation to liver cirrhosis, hemochromatosis is a confounder or the event. Although the vaccine was administered intramuscularly, the gluteus is not the conventional site. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-396157, MOD-2021-396175, MOD-2021-396157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up information received on 24 Nov 2021 contains  significant information.Events , product, and history details added, reporter updated to  nurse missed in initial version.; Sender's Comments: This spontaneous case concerns a 56-year-old female patient with medical history of Graves' disease since, Haemochromatosis and Cirrhosis in liver, who experienced the unexpected non serious event of Cellulitis associated with injection site cellulitis. The event occurred between 1 and 5 days after receiving the third dose of mRNA-1273 Vaccine. Patient received the vaccine , all three doses, in the left gluteus and she developed pyrexia, chills and injection site inflammation which spread into her abdomen and was diagnosed as a Cellulitis. Received treatment with amoxicillin and was resolved 8 days later. The rechallenge was not applicable since only information about the third dose was disclosed.  The patients past medical history of immunocompromised  in relation to liver cirrhosis, hemochromatosis is a confounder or the event. Although the vaccine was administered intramuscularly, the gluteus is not the conventional site. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.