Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchioloalveolar carcinoma, Computerised tomogram, Malaise, Pain, Vaccination site pain
Clinical narrative: doctor said she had BAC (slow growing cancer); chronic pain; Her body started feeling weird; When she took the shot it burned but a month later her body did not feel right; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHIOLOALVEOLAR CARCINOMA (doctor said she had BAC (slow growing cancer)) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 051C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:5 mm nodule in the left side of her chest. Lung Cancer.  The patient's past medical history included Lung nodule and Lung cancer.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (chronic pain), VACCINATION SITE PAIN (When she took the shot it burned but a month later her body did not feel right) and MALAISE (Her body started feeling weird). In September 2021, the patient experienced BRONCHIOLOALVEOLAR CARCINOMA (doctor said she had BAC (slow growing cancer)) (seriousness criterion medically significant). At the time of the report, BRONCHIOLOALVEOLAR CARCINOMA (doctor said she had BAC (slow growing cancer)) and PAIN (chronic pain) had not resolved and VACCINATION SITE PAIN (When she took the shot it burned but a month later her body did not feel right) and MALAISE (Her body started feeling weird) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: CT scans confirm it has been 5 mm for the last 10 years. After the shot it grew to 10 mm..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had a 5 mm nodule in her chest on the left side for the last 10-15 years (maybe less). She had gotten CT scans done regularly the last 10 years and the nodule never grew. She smokes but she isn't a heavy smoker. When she took the shot it burned but a month later her body did not feel right. Her body started feeling weird. She felt fatigued, she was sweating and she had wheezing and breathing problems which is not like her because she runs 25 miles per week. She went to the doctor to get another scan. Her doctor called her and said her nodule went up to 10 mm suddenly from the last scan she did. In September she was diagnosed with lung cancer. She states that for 10-15 years her nodule was at 5 mm but all of a sudden it grew to 10 mm after the shot. Her doctor confirmed that this was not caused by cigarettes. She was diagnosed with stage 1 lunch cancer. She went to get a CAT scan and it was confirmed to be hyperactive (confirmed it was cancer). Her other doctor said she had BAC (slow growing cancer). She went to facility where their chief surgeon confirmed it was stage 1 lunch cancer.  They took her whole upper lobe out and nodules out from under her armpit. She states she now has chronic pain and is suffering. She tried acupuncture but she is still in so much pain. They said her next step would be an epidural. She says she can't live like this anymore. She didn't want to blame Moderna but people were telling her it is too much of a coincidence. She says she finds it odd that when she took the shot, she got cancer 4 months later. She now thinks it's from the Moderna shot. She didn't take the other vaccinations.   Concomitant medication was not reported.  Company comment: This is a spontaneous case concerning a 58-year-old, female patient with a history of 10-15 years of a lung nodule, smoker, who experienced the unexpected serious (medically significant) event of Bronchioloalveolar carcinoma. It was reported that the patient had a lung nodule of 5 mm in her lung for the past 10-15 years and that about 3 months after the administration of the second dose of mRNA-1273 vaccine, she was diagnosed with lung cancer. A CT scans confirmed it has grown from 5 mm to 10 mm. She went to surgery and the whole upper lobe and nodules from under her armpit had been removed. Since then, she complaint of chronic pain. This non-serious event is assessed as not related to vaccination since it is secondary to underlying condition and surgery.  No further information on clinical course, investigations and treatment received was available in the report. The event Bronchioloalveolar carcinoma is assessed as not suspected to vaccination as it is better explained by patient's nodule history of 10-15 years, risk factor of smoker and lung cancer type which has a slow development.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2024: Live Follow-up information received on 4 Jan 2024- Non-Significant Follow up information added.