Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Mechanical urticaria, Nausea, Overdose, Pruritus
Clinical narrative: Serum sickness; bronchitis; Hives; urticaria/dermatographism; urticaria/dermatographism; adverse reaction to Moderna COVID-19 vaccine; 3rd dose of Modema COVID-19 vaccine; aerobic bacteria; acne; Bug bite; Body temperature increased; chills; autoimmune disorder; insect bites noted, with some surrounding cellulitis; Short term memory loss; Vertigo; cough; Itchy all over body; Vomitting; Nausea; Rashes on both arms; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disorder) and CELLULITIS (insect bites noted, with some surrounding cellulitis) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy (NSAIDS) and Allergy to vaccine. Concomitant products included MUPIROCIN for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itchy all over body), VOMITING (Vomitting), NAUSEA (Nausea) and RASH (Rashes on both arms). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disorder) (seriousness criterion medically significant), CELLULITIS (insect bites noted, with some surrounding cellulitis) (seriousness criterion medically significant), AMNESIA (Short term memory loss), VERTIGO (Vertigo), COUGH (cough), SERUM SICKNESS (Serum sickness), BRONCHITIS (bronchitis), URTICARIA (Hives), MECHANICAL URTICARIA (urticaria/dermatographism), URTICARIA (urticaria/dermatographism), VACCINATION COMPLICATION (adverse reaction to Moderna COVID-19 vaccine), OVERDOSE (3rd dose of Modema COVID-19 vaccine), BACTERIAL INFECTION (aerobic bacteria), ACNE (acne), ARTHROPOD BITE (Bug bite), BODY TEMPERATURE INCREASED (Body temperature increased) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 23-Jan-2021 at a dose of 50 mg/1 mL; TRIAMCINOLONE for Skin rash, at a dose of UNK, bid and CEFALEXIN (CEPHALEXINE) (oral) for Bacterial infection, at a dose of UNK, bid. At the time of the report, AUTOIMMUNE DISORDER (autoimmune disorder), CELLULITIS (insect bites noted, with some surrounding cellulitis), COUGH (cough), PRURITUS (Itchy all over body), SERUM SICKNESS (Serum sickness), BRONCHITIS (bronchitis), URTICARIA (Hives), MECHANICAL URTICARIA (urticaria/dermatographism), URTICARIA (urticaria/dermatographism), VACCINATION COMPLICATION (adverse reaction to Moderna COVID-19 vaccine), BACTERIAL INFECTION (aerobic bacteria), ACNE (acne), ARTHROPOD BITE (Bug bite), BODY TEMPERATURE INCREASED (Body temperature increased), CHILLS (chills), VOMITING (Vomitting), NAUSEA (Nausea) and RASH (Rashes on both arms) outcome was unknown, AMNESIA (Short term memory loss) and VERTIGO (Vertigo) had not resolved and OVERDOSE (3rd dose of Modema COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) 99.1°F and 99.9 (High) 99.9°F.         High spike protein was noted Crosslinked with MOD21-119344  and others  The patient need to be treated with a combination of antihistamines which would cause drowsiness, need to be executed for 2 weeks. The patient took Hydroxycholorqine an hour before her 3rd dose of Modema COVID-19 vaccine and no adverse reaction. The patient started Keflex Capsule, 500 MG, 1 capsule, Orally, BID, 10 days, 20 Capsule, Refills include O. The patient also had been swabbed for a culture for her acne and her lab results showed she had aerobic bacteria. The patient had Staph infection.  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.   This case was linked to MOD-2021-064882 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information received contains Non significant Information. On 13-Jul-2021: Additional information received new events were added On 13-Jul-2021: additional info received included no new significant information On 14-Jul-2021: Significant Follow Up included newevents (Bronchitis, Hives) updated. On 14-Jul-2021: Follow up correspondence attached included no new information On 14-Jul-2021: NNI Case On 14-Aug-2021: Follow-up received included: Medical history allergies to morphine derivatives, NSAIDS and COVID19 Vaccine IModerna were added. Lab data body temperature was added. Concomitant medication Mupirocin  was added and treatment medications Triamcinolone and Cephalexin were added. Events Vertigo, short term memory loss, body temperature increased, urticaria, Dermatographism, chills, 3rd dose of Modema COVID-19 vaccine, autoimmune disorder, adverse reaction to Moderna COVID-19 vaccine, aerobic bacteria and acne were 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.