Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Muscle spasms, Myalgia, Productive cough
Clinical narrative: pulmonary vascular congestion; really bad cough, cough was persistent; Her first dose was on 22sep2021 lot number 021C21A. Her second dose was on 25feb2022 lot number 084J21A.; headache; body aches; back and hips hurt like cramps; back and hips hurt like cramps; voice became scratchy; could feel and hear rattling and crackling in her chest; cough was waking her up at night; producing clear phlegm; could feel and hear rattling and crackling in her chest; back and hips hurt like cramps; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (pulmonary vascular congestion), COUGH (really bad cough, cough was persistent), HEADACHE (headache), MYALGIA (body aches), MUSCLE SPASMS (back and hips hurt like cramps), BACK PAIN (back and hips hurt like cramps), DYSPHONIA (voice became scratchy), BREATH SOUNDS ABNORMAL (could feel and hear rattling and crackling in her chest), SLEEP DISORDER (cough was waking her up at night), PRODUCTIVE COUGH (producing clear phlegm), CHEST DISCOMFORT (could feel and hear rattling and crackling in her chest) and ARTHRALGIA (back and hips hurt like cramps) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A and 021C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) for Blood pressure high.   On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2022, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), MYALGIA (body aches) (seriousness criterion medically significant), MUSCLE SPASMS (back and hips hurt like cramps) (seriousness criterion medically significant), BACK PAIN (back and hips hurt like cramps) (seriousness criterion medically significant), DYSPHONIA (voice became scratchy) (seriousness criterion medically significant), BREATH SOUNDS ABNORMAL (could feel and hear rattling and crackling in her chest) (seriousness criterion medically significant), SLEEP DISORDER (cough was waking her up at night) (seriousness criterion medically significant), PRODUCTIVE COUGH (producing clear phlegm) (seriousness criterion medically significant), CHEST DISCOMFORT (could feel and hear rattling and crackling in her chest) (seriousness criterion medically significant) and ARTHRALGIA (back and hips hurt like cramps) (seriousness criterion medically significant). On 25-Feb-2022, the patient experienced COUGH (really bad cough, cough was persistent) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her first dose was on 22sep2021 lot number 021C21A. Her second dose was on 25feb2022 lot number 084J21A.). On 27-Feb-2022, the patient experienced PULMONARY CONGESTION (pulmonary vascular congestion) (seriousness criterion medically significant). At the time of the report, PULMONARY CONGESTION (pulmonary vascular congestion) had not resolved and COUGH (really bad cough, cough was persistent), HEADACHE (headache), MYALGIA (body aches), MUSCLE SPASMS (back and hips hurt like cramps), BACK PAIN (back and hips hurt like cramps), DYSPHONIA (voice became scratchy), BREATH SOUNDS ABNORMAL (could feel and hear rattling and crackling in her chest), SLEEP DISORDER (cough was waking her up at night), PRODUCTIVE COUGH (producing clear phlegm), CHEST DISCOMFORT (could feel and hear rattling and crackling in her chest), ARTHRALGIA (back and hips hurt like cramps) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Her first dose was on 22sep2021 lot number 021C21A. Her second dose was on 25feb2022 lot number 084J21A.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Body temperature: normal (normal) normal. On an unknown date, Chest X-ray: abnormal (abnormal) pulmonary vascular congestion. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, SARS-CoV-1 test: negative (Negative) negative. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication has been provided. On 25feb2022 she received her second Moderna shot and within 2 hours she developed a really bad cough. She went to the ER on 27feb2022 at 23:00 and was diagnosed with pulmonary vascular congestion. She was not treated, and was referred to a cardiologist to get images of her heart, She will have to see a PCP first though due to insurance and that appointment has been scheduled for 3mar2022 with her PCP. She said that she had a headache, body aches, her back and hips hurt like cramps, her cough was persistent and her voice became scratchy. About 24 hours after receiving the vaccine she could feel and hear rattling and crackling in her chest. The cough was waking her up at night and she was producing clear phlegm. In the ER she had an EKG and full bloodwork done which that all came back normal. She had a chest xray that showed the pulmonary vascular congestion. Both flu and Covid tests in the ER came back negative. Her first dose was on 22sep2021 lot number 021C21A. Her second dose was on 25feb2022 lot number 084J21A. Concomitant medication: lisinopril 40 mg daily or high blood pressure. She consents for safety to follow up. COMPANY COMMENT: This is an Spontaneous case concerning a 47-years-old female patient with  no reported clinical history who experienced the unexpected events  of  PULMONARY CONGESTION, HEADACHE, MYALGIA, MUSCLE SPASMS, BACK PAIN, DYSPHONIA, BREATH SOUNDS ABNORMAL, SLEEP DISORDER, COUGH, PRODUCTIVE COUGH, CHEST DISCOMFORT, ARTHRALGIA and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION occurred unknown  days after 2nd dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The medical history of LISINOPRIL remains a confounder for events "chest discomfort, sleep disorder, cough, productive cough". The case was assessed as serious due to IME; Sender's Comments: COMPANY COMMENT: This is an Spontaneous case concerning a 47-years-old female patient with  no reported clinical history who experienced the unexpected events  of  PULMONARY CONGESTION, HEADACHE, MYALGIA, MUSCLE SPASMS, BACK PAIN, DYSPHONIA, BREATH SOUNDS ABNORMAL, SLEEP DISORDER, COUGH, PRODUCTIVE COUGH, CHEST DISCOMFORT, ARTHRALGIA and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION occurred unknown  days after 2nd dose of RNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The medical history of LISINOPRIL remains a confounder for events "chest discomfort, sleep disorder, cough, productive cough". The case was assessed as serious due to IME