Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: Breast never healed properly; hard time breathing; took the vaccine and was allergic to it; anaphylaxis; sinusitis; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxis) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast lump (lumpectomy on breasts), Needle biopsy NOS and Lumpectomy (breast cancer) in June 2022. Previously administered products included for Lupus erythematosus: Cyclosporine (Doctor normally treats her the same way every 10 to 12 weeks for lupus with Cyclosporine but after the vaccine they could no longer treat her with it.). Past adverse reactions to the above products included No adverse event with Cyclosporine. Concurrent medical conditions included Drug allergy (allergic to narcotics (codeine)), Drug allergy and Lupus erythematosus (Got treated for Lupus in April 2021 sent her body into shock.).    On 22-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jan-2024, the patient experienced ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criterion medically significant) and SINUSITIS (sinusitis). On an unknown date, the patient experienced IMPAIRED HEALING (Breast never healed properly), DYSPNOEA (hard time breathing) and HYPERSENSITIVITY (took the vaccine and was allergic to it). The patient was treated with HYDROXOCOBALAMIN ACETATE (VITAMIN B12 [HYDROXOCOBALAMIN ACETATE]) at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (anaphylaxis) and SINUSITIS (sinusitis) had not resolved and IMPAIRED HEALING (Breast never healed properly), DYSPNOEA (hard time breathing) and HYPERSENSITIVITY (took the vaccine and was allergic to it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: looks good and does not look cancerous..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No Concomitant taken. Patient had previous health condition of Lupus. When Moderna vaccine came out their government authorized patient to get her vaccines which she got them in Jan and Feb of 2021 through the national guard. She got treated for Lupus in April 2021 sent her body into shock. She carries an epi pen with her. She was crumbling in every way. She said they didn't know how much the vaccine messed with immune system.  She reports they got previous Moderna vaccine the last booster. She had arm swelling, fatigue, arm was red, scratched arm until it blead and when she went to the emergency room they said she was having anaphylaxis shot. She was also experienced being nauseous but thought everything was fine. Her doctor normally treats her the same way every 10 to 12 weeks for lupus with Cyclosporine but after the vaccine they could no longer treat her with it and has to wait 5 years before trying it again due to her anaphylaxis so right now she can only get a Vitamin B12 shots. She wears a brace on her back and hands, was unable to drive, cannot take care of themselves, they can't get their medication. They can't afford the CBD cream. She was allergic to narcotics, codeine. She had lumpectomy on both breasts. The first one was in Jun2022 second one was in Dec2022. They started with the needle biopsy a few months before that. Her right breast still oozes, but they can't do anything since it's not blood. Mammogram looks good and does not look cancerous. Breast never healed properly; they wear sports bras all the time. She had a hard time breathing and was having trouble with their lungs. It started with sinusitis and then their doctor sent them to a lung specialist and they put her on an inhaler and a breathing machine to strengthen their lungs and use nasal saline to wash them out.   Company Comment: This is a Spontaneous case concerning a  58-year-old female patient with concurrent medical history of drug allergy and Lupus, who experienced the serious (per medically significant) expected event of Anaphylactic reaction which occurred about 1 year and two months after a dose of mRNA-1273 BIVALENT.222 received as the fifth dose for COVID-19 Vaccination. In view of the long non-suggestive onset latency, causality remains not related with the vaccine dose. The medical history of drug allergy and Lupus remain as confounders. Treatment information was not reported. The benefit-risk relationship of mRNA-1273 BIVALENT.222 is not affected by this report.  She took Moderna doses as respectively 1st dose: 23Jan2021 013L20A 2nd dose: 02Feb2021 006M20A 3rd dose: 29Sep2021 014F21A Next one: 16Mar2022 027L21A Bivalent 22Oct2022 053D22   This case was linked to MOD-2024-756467 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a  58-year-old female patient with concurrent medical history of drug allergy and Lupus, who experienced the serious (per medically significant) expected event of Anaphylactic reaction which occurred about 1 year and two months after a dose of mRNA-1273 BIVALENT.222 received as the fifth dose for COVID-19 Vaccination. In view of the long non-suggestive onset latency, causality remains not related with the vaccine dose. The medical history of drug allergy and Lupus remain as confounders. Treatment information was not reported. The benefit-risk relationship of mRNA-1273 BIVALENT.222 is not affected by this report.