Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood lactate dehydrogenase, Breast cancer, Mammogram, Stress, Therapeutic response unexpected
Clinical narrative: stressors; breast cancer; all of her blisters were gone and she did not have any blister-related symptoms.; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (breast cancer) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ESTRADIOL for an unknown indication.    The patient's past medical history included Non-Hodgkin's lymphoma (did not have to have chemo until 2019) in 2017, Blisters and Chemotherapy. Previously administered products included for Drug use for unknown indication: Neulasta (After taking Neulasta, either the same day or 24 hours after and she would break out into blisters.); for Blisters: Clobetasol (This medication helped but it didn't stop). Past adverse reactions to the above products included Blisters with Neulasta; and No adverse effect with Clobetasol. Concurrent medical conditions included Latex allergy and Oral lichen planus. Concomitant products included HYDROXYCHLOROQUINE for Oral lichen planus, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication.   On 24-Mar-2022, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient started ESTRADIOL (unknown route) at an unspecified dose. On 25-Mar-2022,  after starting mRNA-1273 (Spikevax), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (all of her blisters were gone and she did not have any blister-related symptoms.). In October 2023, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). On an unknown date, the patient experienced STRESS (stressors). At the time of the report, BREAST CANCER (breast cancer), STRESS (stressors) and THERAPEUTIC RESPONSE UNEXPECTED (all of her blisters were gone and she did not have any blister-related symptoms.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, Mammogram: diagnosed with breast cancer. On an unknown date, Blood lactate dehydrogenase: LDH was elevated due to stressors.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patient was diagnosed with non-Hodgkin's lymphoma in 2017 and did not have to have chemo until 2019. After each treatment, she took Neulasta. Neulasta had a latex sensitivity/allergy warning, and she had a sensitivity towards latex, but her doctor insisted she took it anyways because she needed it. After taking Neulasta, either the same day or 24 hours after, she would break out into blisters. These blisters were hard, they did not drain but they were itchy. They were horrible'. Her first blister was found on the outside area of her foot, about midway to the left of her foot. She advised her doctor, but her doctor said just don't scratch it . She ended up going to see a dermatologist and started her on Clobetasol. This medication helped but it didn't stop. She was told by her lymphoma specialist that she could not get the vaccine until she was about 2 years out from finishing chemo. Her specialist had also told her that there was a very high percentage of non-Hodgkin's lymphoma patients that had come in contact with covid that did not survive. She was currently on hydroxychloroquine for oral lichen planus that came up after she stopped chemo. She used to be on Claritin but when she had finished the Claritin, 2 days later her mouth started dissolving, her gum tissue was coming off and her teeth were loosening. She had lesions all over her mouth.  By the time she went in for the 3rd vaccine, her blisters were back and bad as it ever was'. These blisters were specifically on her extremities. The day after her third dose, she woke up and all of her blisters were gone and she did not have any blister-related symptoms. She did not have any blister-related symptoms since that day. She had not gotten any other covid vaccine because she was scared that her blisters might come back. She said that when mosquito bite her then, she got silver dollar size-like reactions. Last September (2023) she was told she was in remission from lymphoma. She asked that why her LDH was elevated and they stated that it was due to stressors. She stated there was a shooting that caused her to be freaked out by the time she got her lab work done but she told her doctor that she did not think stress would put her levels up that quick. Three weeks later, she got her routine mammogram and was diagnosed in October with breast cancer. She stated that she had tubes of estradiol and that was the reason for her breast cancer.   No treatment information was received.  Company Comment: This is a spontaneous case concerning a 69-year-old female patient with a history of Non-Hodgkin's lymphoma and with concomitant use of estradiol, who experienced the serious (due to medically significant) unexpected, event of breast cancer, which occurred on an unknown exact date, on the following year after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. Patient also received mRNA-1273 vaccine as doses 1 and 2. Patient also experienced non-serious event of therapeutic response unexpected. It was reported that after patient taking Neulasta (which she took after her chemo treatment), either the same day or 24 hours after, she would break out into blisters. It was reported that on the following day after third dose, all of her blisters were gone and she did not have any blister-related symptoms. It was reported that Last September 2023 (1 year and 6 months after vaccination) she was told she was in remission from lymphoma. She asked that why her LDH was elevated and they stated that it was due to stressors. Three weeks later, she got her routine mammogram and was diagnosed in October with breast cancer. She stated that she had tubes of estradiol and that was the reason for her breast cancer. Event breast cancer was assessed as not related due to lack of biological plausibility. The mentioned medical history remains as a confounder for event breast cancer. Estradiol was considered as a co-suspect product. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  This case was linked to US-MODERNATX, INC.-MOD-2024-761078 (E2B Linked Report). This case was linked to MOD-2022-595633, MOD-2022-595679 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761078:Same reporter different patient (Husband case)