Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site muscle weakness, Intentional dose omission, Neuralgia
Clinical narrative: cellulitis in three areas on my leg; Every time I get an insect bite it becomes red hot and swollen and requires medical attention.; She is not taking the second Moderna COVID-19 vaccination; infected; inflamed; infection on my eye lid; It was burning like she burned herself/3 hours later it looked like someone took an iron to her arm and burned it. It was painful and hot.; two red welts on the injection site and to the left of it; hard as a rock; itchy; It was painful and hot.; right eye was bright red; huge swelling blew up from under my eye to my eyebrow; it pinched; weakness in the muscle; neuralgia pain; always feels a little lightheaded; hurt, there was weakness in the muscle, neuralgia pain,headache, and fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis in three areas on my leg) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Bee sting and Mosquito bite. Concomitant products included ALPRAZOLAM (XANAX), D-MANNOSE, ELDERBERRY [SAMBUCUS NIGRA], ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN COMPLEX, ROSA CANINA, RUTOSIDE (VITAMIN C COMPLEX [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN COMPLEX;ROSA CANINA;RUTOSIDE]), VITAMIN D3, VITAMIN B12 NOS, VACCINIUM MACROCARPON (AZO-CRANBERRY) and PROBIOTICS NOS for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (weakness in the muscle), NEURALGIA (neuralgia pain), DIZZINESS (always feels a little lightheaded), FATIGUE (hurt, there was weakness in the muscle, neuralgia pain,headache, and fatigue) and HEADACHE (headache). On 23-Feb-2021, the patient experienced OCULAR HYPERAEMIA (right eye was bright red), SWELLING FACE (huge swelling blew up from under my eye to my eyebrow) and EYE PAIN (it pinched). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (It was burning like she burned herself/3 hours later it looked like someone took an iron to her arm and burned it. It was painful and hot.), VACCINATION SITE URTICARIA (two red welts on the injection site and to the left of it), VACCINATION SITE INDURATION (hard as a rock), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (It was painful and hot.). On 28-Feb-2021, the patient experienced EYELID INFECTION (infection on my eye lid). On 04-Mar-2021, the patient experienced VACCINATION SITE INFECTION (infected) and VACCINATION SITE INFLAMMATION (inflamed). On an unknown date, the patient experienced CELLULITIS (cellulitis in three areas on my leg) (seriousness criterion medically significant), ALLERGY TO ARTHROPOD BITE (Every time I get an insect bite it becomes red hot and swollen and requires medical attention.) and INTENTIONAL DOSE OMISSION (She is not taking the second Moderna COVID-19 vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN / POLY B / DEXAMETHASONE) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, INJECTION SITE MUSCLE WEAKNESS (weakness in the muscle), FATIGUE (hurt, there was weakness in the muscle, neuralgia pain,headache, and fatigue) and HEADACHE (headache) had resolved. On 03-Mar-2021, VACCINATION SITE WARMTH (It was burning like she burned herself/3 hours later it looked like someone took an iron to her arm and burned it. It was painful and hot.), VACCINATION SITE INDURATION (hard as a rock) and VACCINATION SITE PAIN (It was painful and hot.) had resolved. At the time of the report, CELLULITIS (cellulitis in three areas on my leg) had not resolved and NEURALGIA (neuralgia pain), DIZZINESS (always feels a little lightheaded), OCULAR HYPERAEMIA (right eye was bright red), SWELLING FACE (huge swelling blew up from under my eye to my eyebrow), EYE PAIN (it pinched), EYELID INFECTION (infection on my eye lid), VACCINATION SITE INFECTION (infected), VACCINATION SITE INFLAMMATION (inflamed), ALLERGY TO ARTHROPOD BITE (Every time I get an insect bite it becomes red hot and swollen and requires medical attention.), VACCINATION SITE URTICARIA (two red welts on the injection site and to the left of it), VACCINATION SITE PRURITUS (itchy) and INTENTIONAL DOSE OMISSION (She is not taking the second Moderna COVID-19 vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: 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. Further information has been requested.   This case was linked to MODERNA, INC.-MOD-2021-036668 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: follow-up was received and contains no new information On 26-Jul-2021: adverse event added and treatment medication added; Sender'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. Further information has been requested. US-MODERNATX, INC.-MOD-2021-036668: