Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Fatigue
Clinical narrative: Around a year ago sometime after primary and second dose she had a bite which progressed to cellulitis; She reported feeling a little tired for a couple days after the first dose.; This spontaneous case was reported by a patient and describes the occurrence of CELLULITIS (Around a year ago sometime after primary and second dose she had a bite which progressed to cellulitis) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Cipro), Drug allergy (Crestor) and Gluten sensitivity (She has a sensitivity to gluten, it is not an allergy.).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced CELLULITIS (Around a year ago sometime after primary and second dose she had a bite which progressed to cellulitis) (seriousness criterion medically significant) and FATIGUE (She reported feeling a little tired for a couple days after the first dose.). In 2021, FATIGUE (She reported feeling a little tired for a couple days after the first dose.) had resolved. At the time of the report, CELLULITIS (Around a year ago sometime after primary and second dose she had a bite which progressed to cellulitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient has not had a positive covid test..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product included unspecified statin drug, low dose beta blocker, vitamins and antibiotic.  Patient did not want to provide past medical history and declined to provide names of concomitant medications. The patient called to report side effects after completing Moderna vaccine Primary series and two Booster doses. The patent stated that never had extreme hypersensitivity to insect bites, but since receiving covid vaccine she had 3-4 episodes of cellulitis after bites. Around a year ago sometime after primary and second dose she had a bite which progressed to cellulitis. She had to sought medical treatment. It occurred again, but was not as bad.  No treatment drug information was reported.  Company Comment:  This is a spontaneous case concerning an 83-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Cellulitis, described as started from an insect bite then progressed to cellulitis, which occurred on the same year after receiving the first dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 9 months prior to the first booster dose of mRNA-1273 vaccine and 16 months prior to the second mRNA-1273 booster dose. It was reported that the patient felt a little tired for a couple days after the first and second dose. The patient also reported that she never had extreme hypersensitivity to insect bites, but since receiving the COVID-19 vaccine she has had 3-4 episodes of cellulitis after bites and sought medical treatment. However, after her first booster, she developed a really big red welt at the site of the vaccination, lasting 4 days before it subsided with no treatment and medical consultation. Two days after receiving her second booster vaccine, patient noted an on and off twitching puffy vein under the left eye and left facial tightness with no numbness. Patient also had a small red spot above the ankle which became swollen and inflamed. She had a medical consultation and was prescribed with antibiotic and steroid. She followed up with the dermatologist and was advised to stop taking the antibiotic because this was causing her stomach problems and burning sensation in her throat. No further details about the diagnostic procedures were provided. Outcome of the event Cellulitis was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-587456, MOD-2022-587455, MOD-2022-587447 (Patient Link).; Sender's Comments: This is a spontaneous case concerning an 83-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Cellulitis, described as started from an insect bite then progressed to cellulitis, which occurred on the same year after receiving the first dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 28 days which falls within the recommended vaccine dosing schedule, approximately 9 months prior to the first booster dose of mRNA-1273 vaccine and 16 months prior to the second mRNA-1273 booster dose. It was reported that the patient felt a little tired for a couple days after the first and second dose. The patient also reported that she never had extreme hypersensitivity to insect bites, but since receiving the COVID-19 vaccine she has had 3-4 episodes of cellulitis after bites and sought medical treatment. However, after her first booster, she developed a really big red welt at the site of the vaccination, lasting 4 days before it subsided with no treatment and medical consultation. Two days after receiving her second booster vaccine, patient noted an on and off twitching puffy vein under the left eye and left facial tightness with no numbness. Patient also had a small red spot above the ankle which became swollen and inflamed. She had a medical consultation and was prescribed with antibiotic and steroid. She followed up with the dermatologist and was advised to stop taking the antibiotic because this was causing her stomach problems and burning sensation in her throat. No further details about the diagnostic procedures were provided. Outcome of the event Cellulitis was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.