Mast cells they went nuts immediately, within minutes,which added another layer to her illness; Mast Cell diseases (unspecified), which have worsened over time; as each shot had a prolonged reaction; This spontaneous case was reported by a patient and describes the occurrence of MAST CELL ACTIVATION SYNDROME (Mast cells they went nuts immediately, within minutes,which added another layer to her illness), CONDITION AGGRAVATED (Mast Cell diseases (unspecified), which have worsened over time) and IMMUNISATION REACTION (as each shot had a prolonged reaction) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product ESTRADIOL (ESTRADIOL TRANSDERMAL SYSTEM) patch for Osteoporosis and Menopausal symptoms.    Patient was a fibro patient.  The patient's past medical history included Skin irritation (with use of the minivelle generic outcome-unknown (skin irritation (Itching))) and Abdominal migraine. Previously administered products included for Product used for unknown indication: Vivelle dot (beginning about 20 years ago (reason unspecified). Patch). Past adverse reactions to the above products included Migraine with Vivelle dot. Family history included Mast cell activation syndrome (mast cell diseases( unspecified)-lifelong personal and strong family history) since an unknown date. Concurrent medical conditions included PEG allergy (sensitive to PEG), Migraine (lifelong migraine syndrome diagnosed during childhood(age unspecified) and they were originally abdominal migraines), Pernicious anemia, Mast cell activation syndrome, Lyme's disease (with coinfections unspecified), Asthma (long going non-chronic asthma, without reported worsening), Myalgic encephalomyelitis (had worsened) since 2011, Chronic fatigue syndrome (had worsened), Osteoporosis (premenopausal osteoporosis), Fragrance sensitivity, Drug allergy (allergy to medication), Food allergy and Menopausal symptoms (Menopause Symptoms). Concomitant products included ESTRADIOL (MINIVELLE) for Osteoporosis and Menopausal symptoms, PROGESTERONE for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and ESTRADIOL (ESTRADIOL TRANSDERMAL SYSTEM) (Transdermal) .05 milligram. On an unknown date, the patient experienced MAST CELL ACTIVATION SYNDROME (Mast cells they went nuts immediately, within minutes,which added another layer to her illness) (seriousness criteria disability and medically significant), CONDITION AGGRAVATED (Mast Cell diseases (unspecified), which have worsened over time) (seriousness criteria disability and medically significant) and IMMUNISATION REACTION (as each shot had a prolonged reaction) (seriousness criterion disability). At the time of the report, MAST CELL ACTIVATION SYNDROME (Mast cells they went nuts immediately, within minutes,which added another layer to her illness), CONDITION AGGRAVATED (Mast Cell diseases (unspecified), which have worsened over time) and IMMUNISATION REACTION (as each shot had a prolonged reaction) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered MAST CELL ACTIVATION SYNDROME (Mast cells they went nuts immediately, within minutes,which added another layer to her illness), CONDITION AGGRAVATED (Mast Cell diseases (unspecified), which have worsened over time) and IMMUNISATION REACTION (as each shot had a prolonged reaction) to be related.    The patient had been on Estrogen patches with oral Progesterone since the age of 49. Patient had stayed in isolation during the pandemic and did not had COVID.  The patient  reported that patient also believed patient's strong family history of disease was related to being 100 percent.  The patient had family medical history (unspecified) out the yin yang. The patient had not crumbled and had no spontaneous fractures. Patient believed patient's conditions all worsened if patient used any product with PEG in it.   Patient reported that the Estradiol Mylan patches did not stick well, so used band aids over the patch.  The patient reported that patient believes that patient's conditions have worsened over time due to using products with PEG, which include patient's current generic Estradiol Mylan patch and the 3 Moderna Covid vaccine all have PEG. It was reported that patient had 2 Moderna shots and a Moderna booster, but then stopped getting the shots as each shot had a prolonged reaction and patient's mast cells they went nuts immediately, within minutes, which added another layer to patient's illness.   The patient had difficulty with reporting timelines and she did not remember much of the timeline, as she stated that her brain did not process fast. The patient did not have the energy to continue talking. Patient's goal was to quiet patient's immune system.  DEXA scans discontinued. Patient reported being 100% homebound due to  current state of health.  No treatment medication was provided.  Company comment: This spontaneous case concerns a 74-year-old female patient with relevant medical history of Mast cell activation syndrome(also family history of mast cell disease), chronic Lymes Disease, co-infections, Asthma, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, allergies(Polyethylene glycol allergy), menopause, osteoporosis reported, who experienced the serious(Disability/medically significant), unexpected events of Mast cell activation syndrome and Condition aggravated, serious(Disability), unexpected event of Immunisation reaction in the context of a dose mRNA-1273.222 bivalent vaccine in the COVID-19 vaccination series. Latency cannot be assessed since onset date of events and date of vaccination was not disclosed. It was reported that patient was on Estrogen patches with oral Progesterone. Her conditions worsened after use of co suspect generic Estradiol Mylan patch and the 3 Moderna Covid vaccines (all have PEG). It was reported that, she stopped getting the shots as each shot had a prolonged reaction and her mast cells went to nuts immediately, within minutes, which added another layer to her illness. Patient reported being 100 percent homebound due to her current state of health. No information on detailed clinical course with supporting investigations and treatment received was available in the report. Outcome of the events was not resolved at the time of report.  The relevant medical history along with family history of mast cell disease remains as confounder to the events. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   This case was linked to MOD-2023-704892 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with relevant medical history of Mast cell activation syndrome(also family history of mast cell disease), chronic Lymes Disease, co-infections, Asthma, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, allergies(Polyethylene glycol allergy), menopause, osteoporosis reported, who experienced the serious(Disability/medically significant), unexpected events of Mast cell activation syndrome and Condition aggravated, serious(Disability), unexpected event of Immunisation reaction in the context of a dose mRNA-1273.222 bivalent vaccine in the COVID-19 vaccination series. Latency cannot be assessed since onset date of events and date of vaccination was not disclosed. It was reported that patient was on Estrogen patches with oral Progesterone. Her conditions worsened after use of co suspect generic Estradiol Mylan patch and the 3 Moderna Covid vaccines (all have PEG). It was reported that, she stopped getting the shots as each shot had a prolonged reaction and her mast cells went to nuts immediately, within minutes, which added another layer to her illness. Patient reported being 100 percent homebound due to her current state of health. No information on detailed clinical course with supporting investigations and treatment received was available in the report. Outcome of the events was not resolved at the time of report.  The relevant medical history along with family history of mast cell disease remains as confounder to the events. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.