Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Headache, Thrombosis
Clinical narrative: COPD; blood clots; headaches; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and THROMBOSIS (blood clots) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 029L20) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included H1N1 influenza and Clot blood (He added that he had been taking medication for the blood clot.). Previously administered products included for Product used for unknown indication: flu shot in 2014. Past adverse reactions to the above products included H1N1 influenza with flu shot. Concomitant products included APIXABAN (ELIQUIS) for Clot blood.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-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 HEADACHE (headaches). On an unknown date, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (blood clots) (seriousness criterion medically significant). The patient was hospitalized from 10-Feb-2024 to 12-Feb-2024 due to CHRONIC OBSTRUCTIVE PULMONARY DISEASE. The patient was treated with OXYGEN for COPD, at an unspecified dose and frequency. At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) and HEADACHE (headaches) had not resolved and THROMBOSIS (blood clots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has no history of any previous COVID-19 diagnosis. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. He added that he had been taking medication for the blood clot although he had been cleared but reevaluation would be done in November to see if he needs to stay on it. He had headaches ever since the vaccination and at the first weekend of February this year, he ended up drawing blood clots bilaterally in both the lungs. Reporter stated that he was a retired critical  nurse but calling as a patient. He added that he constantly had headaches and then stated that at this moment it's probably "3 quarter global headache". He stated that he started having the headaches after the 2nd dose. He also added that the dose given to him was probably a half CC. He stated that he never had the headaches before and that he doesn't think they're fun.  Patient added he was in the ICU for 3 days on the first Saturday of February 2024 because he couldn't breathe. He couldn't get his oxygen saturation to come up so he called an ambulance. At present, he was on oxygen for his COPD. Reporter causality was not reported.   Company comment : This is a spontaneous case, concerns an 80-year-old male patient with medical history of H1N1 influenza and Clot blood under treatment  who experienced the unexpected serious (due to medically significant) AESI of thrombosis and the unexpected serious (due to medically significant and hospitalization) event of chronic obstructive pulmonary disease which occurred unknown days after receiving a dose of mRNA-1273 vaccine which was the second dose of COVID-19 vaccination schedule. It was reported that he couldn't get his oxygen saturation to come up so he called an ambulance and he was in the ICU for 3 days because he couldn't breathe; at present, he was on oxygen for his COPD. The outcome of the event chronic obstructive pulmonary disease was reported as not resolved and the outcome of the event thrombosis was reported as unknown. The medical history of influenza is a contributor for chronic obstructive pulmonary disease event and clot blood for the event thrombosis. The benefit-risk relationship mRNA-1273 vaccine is not affected by this report.