Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: three months later, cellulitis in my leg/second bout of cellulitis/a month ago, I got it again in my right leg for 10 days/then I got it on my left leg/I thought I'd lose my leg; This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (three months later, cellulitis in my leg/second bout of cellulitis/a month ago, I got it again in my right leg for 10 days/then I got it on my left leg/I thought I'd lose my leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 011A21A and 031L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CELLULITIS (three months later, cellulitis in my leg/second bout of cellulitis/a month ago, I got it again in my right leg for 10 days/then I got it on my left leg/I thought I'd lose my leg) (seriousness criterion medically significant). The patient was treated with CEFALEXIN (KEFLEX) at an unspecified dose and frequency and DAPTOMYCIN at an unspecified dose and frequency. At the time of the report, CELLULITIS (three months later, cellulitis in my leg/second bout of cellulitis/a month ago, I got it again in my right leg for 10 days/then I got it on my left leg/I thought I'd lose my leg) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Three months after the second Moderna dose, patient came down with cellulitis in her leg. She never had that in her life. The doctors couldn't find any entry point where the bacteria could have gotten in.  After the booster shot in November 2021, about a week after that, she got a second bout of cellulitis. It was really really severe. Patient took medical care in urgent care in November 2021. It was so bad that she was on antibiotics for 21 days by mouth. It wouldn't clear it up, so she had IV infusion antibiotics for a whole week. That cleared it up. A month ago, she got it again in her right leg for 10 days. Antibiotics cleared it up. Then she got it on her left leg. She finished taking antibiotics. In less than a year, she had cellulitis four times. She stated it might be a coincidence.  She got a one-time IV antibiotic in the hospital, but she did not know the name of it. Company comment: This spontaneous case concerns a 69-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Cellulitis. The event occurred approximately 3 months after administration of second dose of mRNA-1273, the first dose was given 28 days prior, and the third dose was given 251 days later. It has been reported that 3 months after the second dose of mRNA-1273, patient experienced cellulitis on her leg and after the booster dose the event recurred. The event was severe when it recurred, she sought consult and was given antibiotics for 21 days to no effect, eventually antibiotics via IV route was given for 7 days which cleared her of the symptom. Approximately 1 month before this report, her cellulitis recurred which resolved by taking oral antibiotics, again the cellulitis recurred and she took oral antibiotics for 7 days. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgment.; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of Cellulitis. The event occurred approximately 3 months after administration of second dose of mRNA-1273, the first dose was given 28 days prior, and the third dose was given 251 days later. It has been reported that 3 months after the second dose of mRNA-1273, patient experienced cellulitis on her leg and after the booster dose the event recurred. The event was severe when it recurred, she sought consult and was given antibiotics for 21 days to no effect, eventually antibiotics via IV route was given for 7 days which cleared her of the symptom. Approximately 1 month before this report, her cellulitis recurred which resolved by taking oral antibiotics, again the cellulitis recurred and she took oral antibiotics for 7 days. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgment.