Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pneumonia, SARS-CoV-2 test, Vertigo
Clinical narrative: In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was reported by reporter.  Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times.         On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.