Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19 immunisation, Electrocardiogram, Electrocardiogram T wave abnormal, Fibrin D dimer
Clinical narrative: Then she felt like there was fluid in her lungs/ The patient is still feeling sick after the vaccine/She also felt her breathing slowed down/She also developed a mild intermittent cough/horrible fatigue/felt tired/She is exhausted when she slept; Patient had received 2-dose primary series of Pfizer COVID-19 vaccine prior to mRNA-1273.222 vaccination; Patient had received 2-dose primary series of Pfizer COVID-19 vaccine prior to mRNA-1273.222 vaccination; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY OEDEMA (Then she felt like there was fluid in her lungs/ The patient is still feeling sick after the vaccine/She also felt her breathing slowed down/She also developed a mild intermittent cough/horrible fatigue/felt tired/She is exhausted when she slept) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Foot surgery in 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot number: EW0151) on 07-Apr-2021, Pfizer (Dose 2 and Lot number: EW0171) on 28-Apr-2021. Past adverse reactions to the above products included Fatigue with Pfizer; and No adverse event with Pfizer. Concurrent medical conditions included Sulfonamide allergy (sulfa), Heterozygous familial hypercholesterolaemia (Familial heterozygous hypocholesteremia) since 2015, Chronic migraine since 2014 and Lipid metabolism disorder (lipid disorder). Concomitant products included ESTRADIOL, LEVONORGESTREL (CLIMARA PRO) and ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL AND NORETHINDRONE) for an unknown indication.    On 10-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient had received 2-dose primary series of Pfizer COVID-19 vaccine prior to mRNA-1273.222 vaccination) and COVID-19 IMMUNISATION (Patient had received 2-dose primary series of Pfizer COVID-19 vaccine prior to mRNA-1273.222 vaccination). In September 2022, the patient experienced PULMONARY OEDEMA (Then she felt like there was fluid in her lungs/ The patient is still feeling sick after the vaccine/She also felt her breathing slowed down/She also developed a mild intermittent cough/horrible fatigue/felt tired/She is exhausted when she slept) (seriousness criterion medically significant). At the time of the report, PULMONARY OEDEMA (Then she felt like there was fluid in her lungs/ The patient is still feeling sick after the vaccine/She also felt her breathing slowed down/She also developed a mild intermittent cough/horrible fatigue/felt tired/She is exhausted when she slept), INTERCHANGE OF VACCINE PRODUCTS (Patient had received 2-dose primary series of Pfizer COVID-19 vaccine prior to mRNA-1273.222 vaccination) and COVID-19 IMMUNISATION (Patient had received 2-dose primary series of Pfizer COVID-19 vaccine prior to mRNA-1273.222 vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, Blood pressure measurement: 72/42. In September 2022, Electrocardiogram: The cardiologist read the patient recent ECG and said that patient had a T-wave abnormality as well as further repolarization abnormality since the prior reading. The rate was faster than the previous record. and Normal. In September 2022, Fibrin D dimer: Normal. In September 2022, Full blood count: Normal. In September 2022, Metabolic function test: Normal. In September 2022, SARS-CoV-2 test: Normal. In September 2022, Troponin: Normal. On an unknown date, Electrocardiogram T wave abnormal: Abnormal.         The patient received Moderna first booster on 28-Oct-2021 lot number was ??0F21A and Moderna second booster on 03-Apr-2022 lot number 066K21A. The patient had put HRT patch in the morning of vaccination. The patient linked the event fluid in lung was due to air quality. The patient reported that she had a lipid disorder and a T-wave abnormality, so patient had a previous ECG to compare it to. The patient reported that after the second Pfizer dose, patient also felt fatigue, but did not had the feeling in chest. The patient removed the hormone patch on 14-Sep-2022 because it kept falling off and then also started taking unspecified pills on 14-Sep-2022. The patient had 3 home tests with result provided as normal. Patient reported that she was exhausted when she slept and woke up really exhausted and fatigue was pretty bad. No other treatment information was provided.  Company Comment: This is a spontaneous case, reported by a patient, concerning a 55-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Pulmonary oedema, reported as fluid in the lungs, which occurred on the same month after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. Patient had received 2-dose primary series of Pfizer COVID-19 vaccine with adverse event of fatigue, approximately 16 months and 1 week prior to mRNA-1273.222 vaccination (Interchange of vaccine products and Revaccination with different COVID-19 vaccine). Patient also received 2 previous doses of Moderna COVID-19 vaccine as 3rd and 4th COVID-19 vaccines. It was reported that the patient had horrible fatigue, exhausted, slowed breathing, mild intermittent cough, feeling of fluid in the lungs and blood pressure of 72/42. Patient underwent ECG and cardiologist's reading revealed T-wave abnormality with faster rate and further repolarization abnormality compared to the previous ECG. No further details about the treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a patient, concerning a 55-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest Pulmonary oedema, reported as fluid in the lungs, which occurred on the same month after receiving a dose of mRNA-1273.222 as the fifth dose of COVID-19 vaccine. Patient had received 2-dose primary series of Pfizer COVID-19 vaccine with adverse event of fatigue, approximately 16 months and 1 week prior to mRNA-1273.222 vaccination (Interchange of vaccine products and Revaccination with different COVID-19 vaccine). Patient also received 2 previous doses of Moderna COVID-19 vaccine as 3rd and 4th COVID-19 vaccines. It was reported that the patient had horrible fatigue, exhausted, slowed breathing, mild intermittent cough, feeling of fluid in the lungs and blood pressure of 72/42. Patient underwent ECG and cardiologist's reading revealed T-wave abnormality with faster rate and further repolarization abnormality compared to the previous ECG. No further details about the treatments were provided. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.