Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast cancer female, COVID-19, Pancreatic cyst, SARS-CoV-2 test, Spleen disorder
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; Diagnosis of COVID on 15JAN2023 after having received doses of Pfizer and Moderna vaccines (NOS) from 2020 through "2 years ago.")/Sneezing/Coughing; This spontaneous case was reported by a patient and describes the occurrence of 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), PANCREATIC CYST (She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen) and SPLEEN DISORDER (She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen) in a 64-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) in 2020 and Pfizer (Dose 1) in 2020. Past adverse reactions to the above products included No adverse effect with Pfizer and Pfizer. 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.) and Gallbladder disorder (Being sick a little bit from the gallbladder problems, that she may have remove it.).   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 15-Jan-2023, 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 22-May-2023, 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 13-Oct-2023, 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). The patient was treated with Surgery (Lumpectomy) for Breast cancer female; Surgery (Pancreatomy) for Pancreatic cyst and Surgery (Splenectomy) for Spleen disorder. At the time of the report, 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), PANCREATIC CYST (She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen) and SPLEEN DISORDER (She had precancerous cyst in her pancreas she had to lose half her pancreas and her entire spleen) outcome was unknown and 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) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2023, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  It was reported that patient had 2 Pfizer COVID vaccines (in 2020) followed by 4 boosters between Moderna and Pfizer (dates were unspecified) between 2020 and 2 years ago.   Patient reported that she does not have spleen  Patient was hardly sick with COVID.  Company comment-  This is a spontaneous case, concerning a 64-year-old 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 and the non-serious event of Covid-19. The events occurred the following year after a dose of SPIKEVAX COVID-19 VACCINE NOS vaccine, given as an unknown dose of Covid vaccination schedule. She received primary schedule with co-suspect TOZINAMERAN vaccine. It was reported that on 15-Jan-2023, SARS-CoV-2 test was Positive, on May-2023 she had precancerous cyst in her pancreas and she lost half pancreas and her entire spleen, and in  October 13, 2023, she had two different types of breast cancer, and underwent a lumpectomy in her right breast. The outcome of the event Covid-19 was reported as resolved and the outcome of the rest of the events was reported as unknown. As per data available to date, there is no evidence that mRNA-1273 vaccine can cause cancer or relapses and vaccine does not modify DNA, then the events breast cancer female, pancreatic cyst and spleen disorder were considered "not related" to the vaccine. The medical history of Type 2 diabetes mellitus is a contributor for the Covid-19 event. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to MOD-2024-774192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Sep-2024: Live Follow up received that contains non-significant information includes references were added.