Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Vomiting, Wheezing
Clinical narrative: chills; pulmonary embolism in my bottom left lung; left arm was swelling up; Nausea; hypersensitivity reaction; breathing/Chest pains; Difficulty swallowing; palpitations; Hoarseness; Feeling hot; Flushing; Wheezing; vomiting; she couldn't breath; now she has a very bad cough; very high levels of inflamation in my body; stiffness in her hands; she can't move her fingers; bones hurting; her tongue swollen; earache; felt she was going to have a heart attack; hyperventilating; joints hurting/wrist pain; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jun-2021. The most recent information was received on 27-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism in my bottom left lung), HYPERSENSITIVITY (hypersensitivity reaction), CHEST PAIN (breathing/Chest pains), DYSPHAGIA (Difficulty swallowing), PALPITATIONS (palpitations), DYSPHONIA (Hoarseness), FEELING HOT (Feeling hot), FLUSHING (Flushing), WHEEZING (Wheezing), PERIPHERAL SWELLING (left arm was swelling up), NAUSEA (Nausea), CHILLS (chills) and VOMITING (vomiting) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Asthma (Pulmonary embolism/ admitted into hospital) since 12-Jul-2021. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma, GABAPENTIN for Nerve pain, SERTRALINE HYDROCHLORIDE (ZOLOFT), BUSPIRONE, QUETIAPINE FUMARATE (SEROQUEL), DOCUSATE SODIUM (COLACE) and HYDROCHLOROTHIAZIDE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction) (seriousness criterion hospitalization), CHEST PAIN (breathing/Chest pains) (seriousness criterion hospitalization), DYSPHAGIA (Difficulty swallowing) (seriousness criterion hospitalization), PALPITATIONS (palpitations) (seriousness criterion hospitalization), DYSPHONIA (Hoarseness) (seriousness criterion hospitalization), FEELING HOT (Feeling hot) (seriousness criterion hospitalization), FLUSHING (Flushing) (seriousness criterion hospitalization), WHEEZING (Wheezing) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On 12-Jul-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism in my bottom left lung) (seriousness criteria hospitalization and medically significant) and PERIPHERAL SWELLING (left arm was swelling up) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion hospitalization), DYSPNOEA (she couldn't breath), COUGH (now she has a very bad cough), INFLAMMATION (very high levels of inflamation in my body), MUSCULOSKELETAL STIFFNESS (stiffness in her hands), MOBILITY DECREASED (she can't move her fingers), BONE PAIN (bones hurting), SWOLLEN TONGUE (her tongue swollen), EAR PAIN (earache), CARDIAC DISCOMFORT (felt she was going to have a heart attack), HYPERVENTILATION (hyperventilating) and ARTHRALGIA (joints hurting/wrist pain). The patient was hospitalized on 30-Apr-2021 due to CHEST PAIN, CHILLS, DYSPHAGIA, DYSPHONIA, FEELING HOT, FLUSHING, HYPERSENSITIVITY, NAUSEA, PALPITATIONS, VOMITING and WHEEZING, then on 12-Jul-2021 due to PERIPHERAL SWELLING and PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism in my bottom left lung), HYPERSENSITIVITY (hypersensitivity reaction), CHEST PAIN (breathing/Chest pains), DYSPHAGIA (Difficulty swallowing), PALPITATIONS (palpitations), DYSPHONIA (Hoarseness), FEELING HOT (Feeling hot), FLUSHING (Flushing), WHEEZING (Wheezing), PERIPHERAL SWELLING (left arm was swelling up), NAUSEA (Nausea), CHILLS (chills), VOMITING (vomiting), DYSPNOEA (she couldn't breath), COUGH (now she has a very bad cough), INFLAMMATION (very high levels of inflamation in my body), MUSCULOSKELETAL STIFFNESS (stiffness in her hands), MOBILITY DECREASED (she can't move her fingers), BONE PAIN (bones hurting), SWOLLEN TONGUE (her tongue swollen), EAR PAIN (earache), CARDIAC DISCOMFORT (felt she was going to have a heart attack), HYPERVENTILATION (hyperventilating) and ARTHRALGIA (joints hurting/wrist pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Blood pressure systolic: abnormal mmHg (abnormal) Abnormal. On 30-Apr-2021, Heart rate: abnormal (abnormal) Irregular heart rate. On 30-Apr-2021, Respiration abnormal: abnormal per minute (abnormal) abnormal. On an unknown date, Blood test: abnormal (abnormal) very high levels of inflammation in my body..         Concomitant medications: Asthma inhaler Treatment medications : Pain medicine.  Patient did not have history of Hives or urticaria, Hay fever, Anaphylaxis, Hypersensitivity reactions.  On 12-July-2021, Patient went to emergency room because left arm was swelling up and both wrist and hands, finger were hurting. Started getting chest pain while waiting in lobby, was admitted into hospital that day. They found a pulmonary embolism in bottom left lung. Never showed signs of bloods in blood work.  Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-243347 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Added Patient demographic, other medical history, Lab data, event added. Case Upgraded to serious.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.