Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Pancreatic cyst, Spleen disorder, Uterine leiomyoma
Clinical narrative: I had breast cancer last year or two / I had two different types of breast cancer, a lumpectomy in my right breast; She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen; She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen; fibroids, five cervical fibroids that are benign; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-774202 (Moderna).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), in 2022 as dose number unknown (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes Mellitus" (ongoing), notes: Due to this it takes her longer to get better from any cuts or bruises or anything; "Gallbladder Disorder" (ongoing), notes: sick a little bit from the gallbladder problems, that she may have remove it; "Thyroid Mass/Thyroid nodule" (ongoing), notes: had nodules in the thyroid, but they were non-cancerous; "Abdominal pain upper/pains in stomach", start date: 2018 (ongoing), notes: way back in 2018, 2019 prior to getting those vaccines; "pains in back", start date: 2018 (ongoing), notes: way back in 2018, 2019 prior to getting those vaccines; "Food allergy" (ongoing), notes: Reactions only last for 24-48 hours; "Seasonal allergy" (ongoing), notes: allergies to trees, reactions only last for 24-48 hours; "High cholesterol/ Blood cholesterol increased" (unspecified if ongoing); "Gallstones/ Cholelithiasis" (unspecified if ongoing); "hernia" (unspecified if ongoing); "Hernia repaired" (not ongoing); "pollen allergy" (ongoing), notes: reactions only last for 24-48 hours; "allergy to trees" (ongoing), notes: reactions only last for 24-48 hours. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 2020, for COVID-19 Immunization; Bnt162b2 (Dose 2, Single), administration date: 2020, for COVID-19 Immunization. The following information was reported: PANCREATIC CYST (hospitalization), SPLEEN DISORDER (hospitalization) all with onset 22May2023, outcome "unknown" and all described as "She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen"; BREAST CANCER FEMALE (hospitalization, medically significant) with onset 13Oct2023, outcome "unknown", described as "I had breast cancer last year or two / I had two different types of breast cancer, a lumpectomy in my right breast"; UTERINE LEIOMYOMA (non-serious), outcome "unknown", described as "fibroids, five cervical fibroids that are benign". Therapeutic measures were taken as a result of breast cancer female, pancreatic cyst, spleen disorder. Clinical Course: Family history included Dementia (mother had dementia), Heart failure (Mother), Colloid brain cyst (mother had inoperable brain cyst), Hypertension (Mother) and COVID-19 (Patient lost her mother to COVID whom had at least 3 times tested positive from Oct2020 to Feb2022, and uncle also died of COVID). Concurrent medical conditions included Type 2 diabetes mellitus (Due to this it takes her longer to get better from any cuts or bruises or anything.), Gallbladder disorder (Being sick a little bit from the gallbladder problems, that she may have remove it.), Thyroid nodule (she had nodules in the thyroid, but they were non-cancerous), Stomach pain (Patient had pains in stomach and back, way back in 2018, 2019 prior to getting those vaccines), Food allergy (reactions only last for 24-48 hours) and Pollen allergy (allergies to trees, reactions only last for 24-48 hours). In 2022, the patient received dose of Spikevax Nos (Spikevax Nos) (unknown route) 1 dosage form. On an unknown date, the patient received dose of Tozinameran (Pfizer Biontech Covid-19 Vaccine) (unknown route) 1 dosage form. On 15Jan2023, the patient experienced COVID-19 (Diagnosis of COVID on 15Jan2023 after having received doses of Pfizer and Moderna vaccines (NOS) from 2020 through "2 years ago.") /Sneezing/Coughing). On 22May2023, the patient experienced Pancreatic cyst (She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen) (seriousness criterion hospitalization) and Spleen Disorder (She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen) (seriousness criterion hospitalization). On 13Oct2023, the patient experienced Breast Cancer Female (I had breast cancer last year or two / I had two different types of breast cancer, a lumpectomy in my right breast) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced Uterine Leiomyoma (fibroids, five cervical fibroids that are benign). The patient was treated with Surgery (Lumpectomy) for Breast cancer female; Surgery (Pancreatomy) for Pancreatic cyst and Surgery (Splenectomy) for Spleen disorder. It was reported that had 2 Pfizer COVID vaccine (in 2020) followed by 4 boosters between Moderna and Pfizer (dates were unspecified) between 2020 and 2 years ago. Patient reported that she probably had the pre-cancerous, had these cyst and tumours before she ever got those vaccines. She had a spleen which was imperative. She had splenectomy last year and lost her entire spleen. She had hernia repaired. She reiterated that she never had a reaction to any other Moderna boosters ever until last 11Sep2024 within an hour after she was vaccinated, she started to have side effects.   Company comment: This is a spontaneous case, concerning a female patient with medical history of Type 2 diabetes mellitus, who experienced the serious (due to medically significant and hospitalization) unexpected event of breast cancer female; the unexpected serious (due to hospitalization) events of pancreatic cyst and spleen disorder among other non-serious events, on following year of one dose of SPIKEVAX COVID-19 VACCINE NOS vaccine, dose not reported, but since the exact vaccination date was not reported, latency could not be properly assessed. She received as primary schedule two doses of TOZINAMERAN vaccine. The company causality for the events was assessed as not related, due to lack of biologic plausibility. No further clinical information was available for medical review. Co-suspect booster dose of TOZINAMERAN vaccine remains as a confounder. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400271774 Same patient/vaccine, different dose/event;