Received Sep 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Bronchiectasis/Bronchitis; Pneumonia; COPD; Lung cancer; This spontaneous case was reported by a consumer and describes the occurrence of LUNG NEOPLASM MALIGNANT (Lung cancer), BRONCHIECTASIS (Bronchiectasis/Bronchitis), PNEUMONIA (Pneumonia) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax. Past adverse reactions to the above products included No adverse effect with Spikevax. Concomitant products included Estrogens conjugated (Premarin) for an unknown indication. In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In November 2024, the patient experienced LUNG NEOPLASM MALIGNANT (Lung cancer) (seriousness criteria hospitalization and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criterion hospitalization). On an unknown date, the patient experienced BRONCHIECTASIS (Bronchiectasis/Bronchitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 14 days due to BRONCHIECTASIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, LUNG NEOPLASM MALIGNANT and PNEUMONIA. At the time of the report, LUNG NEOPLASM MALIGNANT (Lung cancer), BRONCHIECTASIS (Bronchiectasis/Bronchitis), PNEUMONIA (Pneumonia) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. It was reported that patient had never received a Pfizer COVID-19 vaccine. Caller mentioned that from the beginning to the last one, patient had received the MODERNA vaccine. Caller also mentioned that patient received the MODERNA COVID-19 vaccine just before she ended up in the hospital with pneumonia and bronchitis. Caller explained that she didn't even know she had pneumonia when she went to the emergency room at that time, she wasn't on oxygen at that point, but she was on oxygen after that. Additionally, caller stated that she had been in the hospital the previous number and that on that particular day in November, patient woke up and didn't feel right. Caller explained that she was uncomfortable with the fact that Pfizer was aware that she had been hospitalized for 14 days when, to her knowledge, she did not receive a Pfizer product. During call, caller explained that patient had taken PREMARIN for a decade or more, but that patient had never experienced an adverse reaction. When asked whether PREMARIN was mentioned within letter sent by, patient stated that it did not. Patient got 4 breathing treatments a day which was a bit much.; Reporter's Comments: Company comment: Events have been assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Premarin