Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pulmonary fibrosis
Clinical narrative: Scarring at the bottom of her right lung; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY FIBROSIS (Scarring at the bottom of her right lung) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia (SARS covid pneumonia for 6 times.), Low blood pressure, Heart rate low and Lung assist device therapy (She went through pulmonary therapy 6 months of 2023 and 6 months of 2024.) from 2023 to 2024. Previously administered products included for Drug use for unknown indication: Albuterol. Past adverse reactions to the above products included No adverse effect with Albuterol. Concurrent medical conditions included Immunocompromised (Severely immunocompromised.), Lung scarring and Non-smoker.    On 10-May-2024, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Sep-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OROPHARYNGEAL PAIN (Sore throat). On an unknown date, the patient experienced PULMONARY FIBROSIS (Scarring at the bottom of her right lung) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy (She went through pulmonary therapy 6 months of 2023 and 6 months of 2024.) for Pulmonary fibrosis. At the time of the report, PULMONARY FIBROSIS (Scarring at the bottom of her right lung) and OROPHARYNGEAL PAIN (Sore throat) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient woke up with a sore throat on 05-Sep-2024 and stated that it had gotten worse. She reported that it got in the throat and went straight down to her lungs and its scary. She had scarring at the bottom of her right lung, and she was under the care of a pulmonologist due to having pneumonia 6 times with SARS COVID. Patient had to stop albuterol because it was ruining her teeth. She reported that her lungs were very sensitive. Patient knows that COVID was going around. She also reported that she had to get well and get the antibiotics and steroids out of her system before receiving Spikevax.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 68-year-old female patient, with relevant medical history of COVID-19 pneumonia (6 episodes), lung scarring, and lung assist device therapy, who experienced the unexpected and serious (due to medically significant) event of Pulmonary fibrosis, which occurred on an unknown date after SPIKEVAX 2023-2024 vaccine, administered as sixth dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. Underlying medical history could be a confounding factor for the event. Non-serious event of Oropharyngeal pain was assessed as not related, due to long latency (4 months). The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2024: Live non-significant follow up received and updated references.