Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19
Symptoms: Mammogram abnormal, Mouth swelling, Periorbital swelling, Peripheral swelling, Rash erythematous
Clinical narrative: Left lymph nodes are enlarged on left side (same arm she received vaccines); Allergic to Balsam of Peru, Cobalt, Formaldehyde, Gold, Quanterium-15/ Worse reaction was to balsam of Peru; Diagnosed with contact dermatitis; Diagnosed with Angioedema/ Neck and face are red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen; This spontaneous case was reported by a patient and describes the occurrence of ANGIOEDEMA (Diagnosed with Angioedema/ Neck and face are red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, High cholesterol, Diabetes and Hypothyroidism (Low thyroid). Concomitant products included LISINOPRIL and HYDROCHLOROTHIAZIDE for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.    On 04-Sep-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 07-Sep-2022, the patient experienced ANGIOEDEMA (Diagnosed with Angioedema/ Neck and face are red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen) (seriousness criterion medically significant). On 19-Sep-2022, the patient experienced DERMATITIS CONTACT (Diagnosed with contact dermatitis). On 06-Oct-2022, the patient experienced HYPERSENSITIVITY (Allergic to Balsam of Peru, Cobalt, Formaldehyde, Gold, Quanterium-15/ Worse reaction was to balsam of Peru). On an unknown date, the patient experienced LYMPHADENOPATHY (Left lymph nodes are enlarged on left side (same arm she received vaccines)). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (Diagnosed with Angioedema/ Neck and face are red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen), DERMATITIS CONTACT (Diagnosed with contact dermatitis), LYMPHADENOPATHY (Left lymph nodes are enlarged on left side (same arm she received vaccines)) and HYPERSENSITIVITY (Allergic to Balsam of Peru, Cobalt, Formaldehyde, Gold, Quanterium-15/ Worse reaction was to balsam of Peru) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Oct-2022, Allergy test: Was told that had worse reaction was to balsam of Peru. Allergic to Balsam of Peru, Cobalt, Formaldehyde, Gold, Quanterium-15.         Patient received dose 1 on 12-Jan-2021 (0.5ml, batch no.: 026L20A), dose 2 on 09-Feb-2021 (0.5ml, batch no.: 032L20A), booster 1 on 22-Oct-2021 (0.25ml, batch no.: 017E21A) and booster 2 on 24-Apr-2022 (0.25ml, batch no.: 057M21A) from Moderna.Patient's HCP thinks it was related to the vaccines, because patient had never had those before. Patient wanted to know if there were any ingredients in the vaccine mentioning what was patient allergic to, or cross sensitivity related to Balsam of Peru or other things that patient was allergic to. Patient asked how long Angioedema last. The patient left lymph nodes were enlarged on left side (same arm where vaccine was received) and scheduled for a biopsy next day on 13-Oct-2022. Patient's symptoms had subsided after 8 days of prednisone. However it came back. Adverse event caused patient to seek medical care (office visit, Urgent care, ER, hospitalized). Patient had never experienced a similar event in the past.  Company comment: This spontaneous case concerns a 69 year old female patient with no relevant medical history reported who experienced Serious ( medically significant ), unexpected event of Angioedema ( Diagnosed with Angioedema/ Neck and face are red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen) . This was accompanied by other non-serious unexpected event of dermatitis contact and non-serious expected events of lymphadenopathy  (nodes are enlarged on left side (same arm she received vaccines) and hypersensitivity  (Allergic to Balsam of Peru, Cobalt, Formaldehyde, Gold, Quanterium-15/ Worse reaction was to balsam of Peru).  . The event angioedema  occurred  3 days post vaccination   with the  mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) , while the event dermatitis contact occurred 15 days post vaccination  , event hypersensitivity occurred  one month , 2 days after the vaccination and the event lymphadenopathy occurred on an unknown date post vaccination with the bivalent vaccine. The initial four doses of Covid 19 vaccine of this patient were all mRNA-1273 vaccine.   It was reported that her .neck, and face were  red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen .She was  diagnosed with Angioedema . Her left Lymph nodes are enlarged on left side(same arm she received vaccines) and she was  scheduled for a biopsy . She was also  diagnosed with Contact Dermatitis . An Allergy testing  was done and was told that her worse reaction was to balsam of Peru. It was also reported that the patient's HCP thinks it was related to the vaccine . The events caused patient to seek medical care  but not all details were provided. Some symptoms  have subsided after 8 days of Prednisone however it was reported that there were recurrences.The use of Balsam of Peru may be considered as a confounder for the event hypersensitivity . The benefit -risk relationship of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69 year old female patient with no relevant medical history reported who experienced Serious ( medically significant ), unexpected event of Angioedema ( Diagnosed with Angioedema/ Neck and face are red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen) . This was accompanied by other non-serious unexpected event of dermatitis contact and non-serious expected events of lymphadenopathy  (nodes are enlarged on left side (same arm she received vaccines) and hypersensitivity  (Allergic to Balsam of Peru, Cobalt, Formaldehyde, Gold, Quanterium-15/ Worse reaction was to balsam of Peru).  . The event angioedema  occurred  3 days post vaccination   with the  mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) , while the event dermatitis contact occurred 15 days post vaccination  , event hypersensitivity occurred  one month , 2 days after the vaccination and the event lymphadenopathy occurred on an unknown date post vaccination with the bivalent vaccine. The initial four doses of Covid 19 vaccine of this patient were all mRNA-1273 vaccine.   It was reported that her .neck, and face were  red, swollen, rashes, face and neck are the worse, legs and body are swelling and swollen .She was  diagnosed with Angioedema . Her left Lymph nodes are enlarged on left side(same arm she received vaccines) and she was  scheduled for a biopsy . She was also  diagnosed with Contact Dermatitis . An Allergy testing  was done and was told that her worse reaction was to balsam of Peru. It was also reported that the patient's HCP thinks it was related to the vaccine . The events caused patient to seek medical care  but not all details were provided. Some symptoms  have subsided after 8 days of Prednisone however it was reported that there were recurrences.The use of Balsam of Peru may be considered as a confounder for the event hypersensitivity . The benefit -risk relationship of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) is not affected by this report.