Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Chills, Cough, Fatigue
Clinical narrative: Lung infection that is either that or pneumonia; The first dose contribute to my issues right now/ I have head to stomach issues now and not before.; Hole in my heart; Made my immune system weak; passed out; Now have brain aneurism (diagnosed while in hospital); tiredness; really lethargic; when I received the vaccine I got a sore arm; feeling weak, not back to 100% with regard to energy or stamina; muscle aches in neck couldn't turn head; nausea; coughing; chills; sweats; headache/severe headache; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection that is either that or pneumonia), INTRACRANIAL ANEURYSM (Now have brain aneurism (diagnosed while in hospital)), LOSS OF CONSCIOUSNESS (passed out), VACCINATION SITE PAIN (when I received the vaccine I got a sore arm), ASTHENIA (feeling weak, not back to 100% with regard to energy or stamina), LETHARGY (really lethargic), NECK PAIN (muscle aches in neck couldn't turn head), NAUSEA (nausea), COUGH (coughing), CHILLS (chills), HYPERHIDROSIS (sweats), HEADACHE (headache/severe headache), FATIGUE (tiredness), VACCINATION COMPLICATION (The first dose contribute to my issues right now/ I have head to stomach issues now and not before.), CARDIAC DISORDER (Hole in my heart), OROPHARYNGEAL PAIN (Sore throat) and IMMUNE SYSTEM DISORDER (Made my immune system weak) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No medical history was reported by patient.  Concurrent medical conditions included Cardiac assistance device user and Headache. Concomitant products included VITAMIN D3 for an unknown indication.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced NECK PAIN (muscle aches in neck couldn't turn head) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), COUGH (coughing) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization), HYPERHIDROSIS (sweats) (seriousness criterion hospitalization), HEADACHE (headache/severe headache) (seriousness criterion hospitalization) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion hospitalization). On 26-Aug-2021, the patient experienced VACCINATION SITE PAIN (when I received the vaccine I got a sore arm) (seriousness criterion hospitalization) and ASTHENIA (feeling weak, not back to 100% with regard to energy or stamina) (seriousness criterion hospitalization). On 29-Aug-2021, the patient experienced LETHARGY (really lethargic) (seriousness criterion hospitalization). On 04-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant). In September 2021, the patient experienced INTRACRANIAL ANEURYSM (Now have brain aneurism (diagnosed while in hospital)) (seriousness criteria hospitalization and medically significant) and FATIGUE (tiredness) (seriousness criterion hospitalization). On an unknown date, the patient experienced PNEUMONIA (Lung infection that is either that or pneumonia) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (The first dose contribute to my issues right now/ I have head to stomach issues now and not before.) (seriousness criterion hospitalization), CARDIAC DISORDER (Hole in my heart) (seriousness criterion hospitalization) and IMMUNE SYSTEM DISORDER (Made my immune system weak) (seriousness criterion hospitalization). The patient was hospitalized from 04-Sep-2021 to 06-Sep-2021 due to ASTHENIA, CARDIAC DISORDER, CHILLS, COUGH, FATIGUE, HEADACHE, HYPERHIDROSIS, IMMUNE SYSTEM DISORDER, INTRACRANIAL ANEURYSM, LETHARGY, LOSS OF CONSCIOUSNESS, NAUSEA, NECK PAIN, OROPHARYNGEAL PAIN, PNEUMONIA, VACCINATION COMPLICATION and VACCINATION SITE PAIN. The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at a dose of 1 dosage form; CEFDINIR for Lung infection, at a dose of (5 days after home); METOPROLOL for Adverse event, at a dose of 1 dosage form once a day; PANTOPRAZOLE for Adverse event, at a dose of 1 dosage form once a day; PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form and IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, PNEUMONIA (Lung infection that is either that or pneumonia) had not resolved, INTRACRANIAL ANEURYSM (Now have brain aneurism (diagnosed while in hospital)), LOSS OF CONSCIOUSNESS (passed out), VACCINATION SITE PAIN (when I received the vaccine I got a sore arm), LETHARGY (really lethargic), NECK PAIN (muscle aches in neck couldn't turn head), NAUSEA (nausea), COUGH (coughing), CHILLS (chills), HYPERHIDROSIS (sweats), HEADACHE (headache/severe headache), FATIGUE (tiredness), VACCINATION COMPLICATION (The first dose contribute to my issues right now/ I have head to stomach issues now and not before.), CARDIAC DISORDER (Hole in my heart), OROPHARYNGEAL PAIN (Sore throat) and IMMUNE SYSTEM DISORDER (Made my immune system weak) outcome was unknown and ASTHENIA (feeling weak, not back to 100% with regard to energy or stamina) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported Eye vitamin - oral - preservision as concomitant medication  Patient reported that she was not back to 100 percent with regard to energy or stamina after first vaccination, before that she was active, walked two miles a day, rode bicycle, played pickle ball  4 times a week.  Patient reported that she was unsure of second vaccine and she saw(in hospital)  four different doctors for four different organs (cardiology, pulmonology, GI, Neurologist), all of them that saw me recommend that I get the second one.  Patient reported that she had no such problems before that, patient went for CT scan from brain to lower chest and result pending.  Treatment included blood thinner that was not specified.  This case concerns a 77-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pneumonia, intracranial aneurism, loss of consciousness, vaccination site pain, asthenia, lethargy, neck pain, nausea, cough, chills, hyperhidrosis, headache, fatigue, abdominal discomfort, cardiac disorder, oropharyngeal pain and immune system disorder. The events occurred approximately 1 to 2 weeks following first dose of Moderna COVID-19 Vaccine and the patient was hospitalized. The patient was diagnosed with brain aneurism while in the hospital and reported to have hole in heart which did not have before, and lung infection. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 77-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pneumonia, intracranial aneurism, loss of consciousness, vaccination site pain, asthenia, lethargy, neck pain, nausea, cough, chills, hyperhidrosis, headache, fatigue, abdominal discomfort, cardiac disorder, oropharyngeal pain and immune system disorder. The events occurred approximately 1 to 2 weeks following first dose of Moderna COVID-19 Vaccine and the patient was hospitalized. The patient was diagnosed with brain aneurism while in the hospital and reported to have hole in heart which did not have before, and lung infection. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.