Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Pneumonia, SARS-CoV-2 test, Sinusitis, Upper respiratory tract infection
Clinical narrative: cognitive function has been impaired because of the fever; Revaccination with different COVID-19 vaccine; interchange of vaccine product; symptoms like pneumonia/Shaking/ cough/ chest congestion/ frontal headache/ myalgia/ chills /rigors/ fever/fever of 102/ 104.7°F; sinusitis; upper respiratory infection type symptoms/Congestion; illness; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONIA (symptoms like pneumonia/Shaking/ cough/ chest congestion/ frontal headache/ myalgia/ chills /rigors/ fever/fever of 102/ 104.7°F) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE in January 2021, PFIZER BIONTECH COVID-19 VACCINE in November 2021, PFIZER BIONTECH COVID-19 VACCINE in December 2021, PFIZER BIONTECH COVID-19 VACCINE in May 2022 and Flu vaccine 30 days prior. Past adverse reactions to the above products included No adverse event with Flu vaccine 30 days prior, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 29-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Oct-2022, the patient experienced PNEUMONIA (symptoms like pneumonia/Shaking/ cough/ chest congestion/ frontal headache/ myalgia/ chills /rigors/ fever/fever of 102/ 104.7°F) (seriousness criterion medically significant), SINUSITIS (sinusitis), UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection type symptoms/Congestion) and ILLNESS (illness). On an unknown date, the patient experienced COGNITIVE DISORDER (cognitive function has been impaired because of the fever), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; CELECOXIB (CELEBREX) ongoing since an unknown date at a dose of 1 dosage form; LEVOFLOXACIN (LEVAQUIN LEVA-PAK) at a dose of 1 dosage form and AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 1 dosage form. At the time of the report, PNEUMONIA (symptoms like pneumonia/Shaking/ cough/ chest congestion/ frontal headache/ myalgia/ chills /rigors/ fever/fever of 102/ 104.7°F), SINUSITIS (sinusitis), UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection type symptoms/Congestion) and ILLNESS (illness) had not resolved and COGNITIVE DISORDER (cognitive function has been impaired because of the fever), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2022, Body temperature: 102 Farad and 104.7 Farad. On an unknown date, Blood test: He has had a CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram (last week) all of which have been normal. He has plans to receive a CT of his abdomen next. There have been no signs of meningitis. On an unknown date, Chest X-ray: He has had a CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram (last week) all of which have been normal. He has plans to receive a CT of his abdomen next. There have been no signs of meningitis. On an unknown date, Computerised tomogram thorax: He has had a CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram (last week) all of which have been normal. He has plans to receive a CT of his abdomen next. There have been no signs of meningitis. On an unknown date, Echocardiogram: He has had a CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram (last week) all of which have been normal. He has plans to receive a CT of his abdomen next. There have been no signs of meningitis. On an unknown date, Laboratory test: He has had a CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram (last week) all of which have been normal. He has plans to receive a CT of his abdomen next. There have been no signs of meningitis. On an unknown date, Magnetic resonance imaging head: He has had a CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram (last week) all of which have been normal. He has plans to receive a CT of his abdomen next. There have been no signs of meningitis. On an unknown date, SARS-CoV-2 test: (Negative) negative for COVID-19 2x.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that at the end of this, patient had about 1 day's relief of the respiratory symptoms. After the Levaquin was finished, patient started a 7-day course of Augmentin which provided a gradual elimination of his cough and congestion. Patient had continued to had a frontal headache and fever every day up until today from these events. Patient also feels his cognitive function has been impaired because of the fever. highest recorded temperature with this illness was 104.7°F.  Company comment: This is a spontaneous case 56 years old male patient, with no relevant medical history, who experienced unexpected serious (medically significant) events of pneumonia, which occurred one day after fifth dose (reported as additional booster) of mRNA-1273 bivalent BA.4/BA.5 vaccine. Patient received four doses of TOZINAMERAN approximelty 5 months prior to the mRNA-1273 bivalent BA.4/BA.5 vaccine (Interchange of vaccine products). It is reported that next day evening patient experienced fever, chills, myalgia, headaches, shaking, rigors, and a fever of 102. This continued for 4 nights until patient also started to have respiratory symptoms including sinusitis, chest congestion, cough, congestions, upper respiratory infection type symptoms and symptoms like pneumonia. Patient started taking low dose Tylenol and Celebrex for reducing symptoms, during symptoms patient tested Covid-19 negative by home test, 7 days after receiving the vaccine he met with primary care doctor who had prescribed Levaquin which he took from Friday to Monday the weekend following the receipt of the vaccine. At the end of this, patient had about 1 day relief of the respiratory symptoms, After the Levaquin was finished, patient started a 7 day course of Augmentin which provided a gradual elimination of his cough and congestion, patient continued to have a frontal headache and fever, Patient feels like his cognitive function has been impaired due to fever, patient highest recorded temperature with this illness was 104.7°F. CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram was done all of which have been normal, patient had a plans to receive a CT of his abdomen next, patient have been no signs of meningitis. At the time of reporting event is not recovered. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments: This is a spontaneous case 56 years old male patient, with no relevant medical history, who experienced unexpected serious (medically significant) events of pneumonia, which occurred one day after fifth dose (reported as additional booster) of mRNA-1273 bivalent BA.4/BA.5 vaccine. Patient received four doses of TOZINAMERAN approximelty 5 months prior to the mRNA-1273 bivalent BA.4/BA.5 vaccine (Interchange of vaccine products). It is reported that next day evening patient experienced fever, chills, myalgia, headaches, shaking, rigors, and a fever of 102. This continued for 4 nights until patient also started to have respiratory symptoms including sinusitis, chest congestion, cough, congestions, upper respiratory infection type symptoms and symptoms like pneumonia. Patient started taking low dose Tylenol and Celebrex for reducing symptoms, during symptoms patient tested Covid-19 negative by home test, 7 days after receiving the vaccine he met with primary care doctor who had prescribed Levaquin which he took from Friday to Monday the weekend following the receipt of the vaccine. At the end of this, patient had about 1 day relief of the respiratory symptoms, After the Levaquin was finished, patient started a 7 day course of Augmentin which provided a gradual elimination of his cough and congestion, patient continued to have a frontal headache and fever, Patient feels like his cognitive function has been impaired due to fever, patient highest recorded temperature with this illness was 104.7°F. CXR, multiple labs and blood tests, CT chest, MRI Brain, and echocardiogram was done all of which have been normal, patient had a plans to receive a CT of his abdomen next, patient have been no signs of meningitis. At the time of reporting event is not recovered. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.