Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Administration site recall reaction, COVID-19, Computerised tomogram, Computerised tomogram thorax, Magnetic resonance imaging head
Clinical narrative: Radiation recall pneumonitis; Radiation recall pneumonitis; This literature-non-study case was reported in a literature article and describes the occurrence of RADIATION PNEUMONITIS (Radiation recall pneumonitis) and ADMINISTRATION SITE RECALL REACTION (Radiation recall pneumonitis) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       The patient's past medical history included Radiotherapy to lung (45 Gy in 15 fractions) in July 2020. Previously administered products included for an unreported indication: Immunochemotherapy (four cycles of first-line systemic therapy with carboplatin, pemetrexed and and pembrolizumab). Concurrent medical conditions included Non-small cell lung cancer metastatic (Received local consolidation radiotherapy to the right lung) and Radiation fibrosis - lung. Concomitant products included PEMETREXED and PEMBROLIZUMAB for Non-small cell lung cancer metastatic.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced RADIATION PNEUMONITIS (Radiation recall pneumonitis) (seriousness criterion medically significant) and ADMINISTRATION SITE RECALL REACTION (Radiation recall pneumonitis) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Radiation pneumonitis and Administration site recall reaction, at a dose of 40 milligram once a day. At the time of the report, RADIATION PNEUMONITIS (Radiation recall pneumonitis) was resolving. Related    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2020, COVID-19: Negative. On 05-Mar-2021, COVID-19: Negative. On 18-Mar-2021, Computerised tomogram thorax: extensive consolidation with surrounding ground-glass opacities and bronchiectasis within the prior radiation therapy portal suggestive of radiation recall type of pneumonitis at eight months after the completion of radiation therapy and after the administration of the second COVID-19 vaccine. On an unknown date, Computerised tomogram: decreasing size of the RUL/mediastinal tumors and the development of grade 1 radiation fibrosis. On an unknown date, Computerised tomogram thorax: lung mass in the upper lobe of the right lung with hypermetabolic uptake of FDG (red arrow) suggesting lung cancer., early post-radiation fibrosis surrounding the treated mass after five month of radiation therapy and interval appearance of a few small scattered multifocal ground-glass opacities with tiny nodular consolidations involving the bilateral lower lobes (possibly represented infectious or inflammatory changes and found to be completely resolved on his subsequent CT chest three months later). On an unknown date, Magnetic resonance imaging head: not reveal any metastatic disease. On an unknown date, Positron emission tomogram: a large bilobed mass of the right upper lobe with the dominant superior mass at 5.4 x 4.2 cm abutting the pleura and a more inferior mass measuring 4.6 x 4.2 cm, as well as multiple involved hilar and mediastinal nodes that measured up to 1.8 cm in short axis, a biopsy-confirmed 1.3-cm rounded lesion in the pancreas was the only site of distant disease and Repated PET demonstrated a partial response in the right upper lobe and mediastinum with the dominant right upper lobe mass decreased to 3.4 x 2.7 cm and the inferior mass to 3.3 x 3.2 cm, as well as complete response in the pancreatic metastasis with no measurable disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RADIATION PNEUMONITIS (Radiation recall pneumonitis) and ADMINISTRATION SITE RECALL REACTION (Radiation recall pneumonitis) to be related.    Molecular analysis of non-small cell lung cancer (NSCLC) revealed no targetable mutations with a programmed death-ligand 1 (PD-L1) expression of 0%. Patient was completed four cycles of first-line systemic therapy with carboplatin, pemetrexed, and pembrolizumab and had no clinically significant side effects due to the therapy. Patient was completed 45 Gy in 15 fractions in July 2020. It was reported that maintenance pemetrexed and pembrolizumab were continued every three weeks for the next eight months with minimal nausea and fatigue. After three to five days of the first dose vaccination administration, he developed a bothersome nonproductive cough.He had no other adverse reactions related to the vaccination that he could remember and denied arm pain, fevers, chills, weakness, hemoptysis, joint aches, or gastrointestinal distress. He continued his therapy with pemetrexed and pembrolizumab. At his next cycle on February 23, he reported to his medical oncologist about a persistent bothersome cough. Thre to four days after second dose of the COVID-19 vaccine, the patient noted that his cough became progressively more severe and frequent. Associated symptoms included increased dyspnea on exertion. The patient was started on prednisone 40 mg daily with a long taper, which quickly improved his symptoms. The authors concluded that given the onset and worsening of symptoms within days of the first and second doses of the COVID-19 vaccine, respectively, it is possible that the inflammatory response to vaccination served as a trigger for radiation recall pneumonitis in this patient.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2022: Live Follow up received by safety on 20-Oct-2022 has email with full text article received and contains  significant information: Reporter information updated, citation details updated, lab data added, product information was updated, event outcome updated.  CC:This literature-non-study case report concerns a 66-year-old male patient with underlying medical history of oligometastatic non-small cell lung cancer, who experienced serious (medically significant) unexpected events of Radiation pneumonitis and Administration site recall pheomenon which were reported as Radiation recall pneumonitis as per the authors. Reportedly, 3-5 days after receiving the first dose of the mRNA-1273 vaccine, the patient developed nonproductive cough and had no other adverse reactions related to the vaccination, as stated. The patient received the second dose of the mRNA-1273 vaccine and his cough became progressively more severe and frequent associated with increased dyspnea on exertion, 3-4 days after this vaccination. CT imaging showed exuberant pneumonitis confined primarily within the prior radiotherapy treatment field. Given the timeliness (at eight months post-irradiation and following administrations of the vaccine), radiation recall pneumonitis was diagnosed. The patient was started on prednisone 40 mg daily with a long taper, which quickly improved his symptoms. The authors concluded that the correlation between the first onset of symptoms just a few days following the first dose of the vaccine followed by significant worsening of symptoms within a few days of the second dose, made a compelling case for radiation recall pneumonitis triggered by the mRNA-1273 vaccine. Radiotherapy in combination with immunotherapy remains a confounding factor for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature-non-study case report concerns a 66-year-old male patient with underlying medical history of oligometastatic non-small cell lung cancer, who experienced serious (medically significant) unexpected events of Radiation pneumonitis and Administration site recall pheomenon which were reported as Radiation recall pneumonitis as per the authors. Reportedly, 3-5 days after receiving the first dose of the mRNA-1273 vaccine, the patient developed nonproductive cough and had no other adverse reactions related to the vaccination, as stated. The patient received the second dose of the mRNA-1273 vaccine and his cough became progressively more severe and frequent associated with increased dyspnea on exertion, 3-4 days after this vaccination. CT imaging showed exuberant pneumonitis confined primarily within the prior radiotherapy treatment field. Given the timeliness (at eight months post-irradiation and following administrations of the vaccine), radiation recall pneumonitis was diagnosed. The patient was started on prednisone 40 mg daily with a long taper, which quickly improved his symptoms. The authors concluded that the correlation between the first onset of symptoms just a few days following the first dose of the vaccine followed by significant worsening of symptoms within a few days of the second dose, made a compelling case for radiation recall pneumonitis triggered by the mRNA-1273 vaccine. Radiotherapy in combination with immunotherapy remains a confounding factor for the reported event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.