Age: 70.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Dehydration, Diarrhoea, Dysstasia, Illness, Pneumonia
Clinical narrative: dehydration; diarrhea; pneumonia; felt so bad he could barely stand; violently ill/sick; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (pneumonia), DEHYDRATION (dehydration) and DIARRHOEA (diarrhea) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Patient had No allergies. Patient Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination was reported as None and patient had never diagnosed with COVID positive test or diagnosis.    On 13-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced DEHYDRATION (dehydration) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea) (seriousness criterion hospitalization). In November 2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and ILLNESS (violently ill/sick). On an unknown date, the patient experienced DYSSTASIA (felt so bad he could barely stand). The patient was hospitalized from 15-Nov-2021 to 16-Nov-2021 due to DEHYDRATION, DIARRHOEA and PNEUMONIA. At the time of the report, PNEUMONIA (pneumonia), DEHYDRATION (dehydration), DIARRHOEA (diarrhea), ILLNESS (violently ill/sick) and DYSSTASIA (felt so bad he could barely stand) had resolved.            Concomitant medications included Unspecified regular/prescribed meds. Patient received the first booster, and the flu shot was given simultaneously. It was reported that after the 1st booster patient was violently ill for two days and on the 14th patient was sick, on 15-Nov-2021, patient ended up in the hospital with dehydration from diarrhea Patient also received the flu vaccine and was experiencing pneumonia and his HCP told him that that was the cause. The next morning he was released and Patient felt so bad he could barely stand. Patient received an unspecified treatment (Patient did not remember the exact medication he took). It was reported that patient symptoms were all gone.  Company comment: This spontaneous case concerns an elderly male patient aged 70 years with no medical history reported, who experienced the unexpected serious (medically significant/hospitalization) event of Pneumonia occurred on an unknown date in Nov.2021 and unexpected serious (hospitalization) events of Dehydration and Diarrhoea occurred two days after receiving first Booster dose of mRNA-1273 vaccine. He also experienced non-serious events of Illness and Dysstasia. After vaccination with 1st Booster patient was violently ill for two days, was hospitalized for dehydration from Diarrhoea. Patient had also received co suspect INFLUENZA VACCINE simultaneously with 1st booster dose of mRNA-1273 vaccine. He was experiencing pneumonia and his HCP told him that Flu Vaccine was the cause. He was discharged the next day. No further details on clinical course, lab results and treatment given were reported.  Patient had received initial schedule of vaccination with Moderna at an interval of 28 days and first booster approximately seven and half months later. Patient elderly age could be risk factor for the event Pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-609591 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly male patient aged 70 years with no medical history reported, who experienced the unexpected serious (medically significant/hospitalization) event of Pneumonia occurred on an unknown date in Nov.2021 and unexpected serious (hospitalization) events of Dehydration and Diarrhoea occurred two days after receiving first Booster dose of mRNA-1273 vaccine. He also experienced non-serious events of Illness and Dysstasia. After vaccination with 1st Booster patient was violently ill for two days, was hospitalized for dehydration from Diarrhoea. Patient had also received co suspect INFLUENZA VACCINE simultaneously with 1st booster dose of mRNA-1273 vaccine. He was experiencing pneumonia and his HCP told him that Flu Vaccine was the cause. He was discharged the next day. No further details on clinical course, lab results and treatment given were reported.  Patient had received initial schedule of vaccination with Moderna at an interval of 28 days and first booster approximately seven and half months later. Patient elderly age could be risk factor for the event Pneumonia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per medical judgement.