Age: 75.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Discomfort, Dyspnoea, Insomnia, Pain, Urine analysis normal
Clinical narrative: Fever / temp was 101.1 / temp was 104.5; SOB; Shaking chills / chills; Coughing; Rhinitis; Oxygen saturation went from 97 to 90% with slow ambulation; Oxygen saturation went from 97 to 90% with slow ambulation; Dehydrated; Hip pain / Joint pain; Body ache; Loss of appetite; Prev dose brand=Moderna / brand=Pfizer; Headache; Vomiting; Diarrhea; Weakness; Exhaustion; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 at 12:00 as dose 4 (booster), single (Lot number: GJ3327) at the age of 75 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Known allergies: IVP dye" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM. Vaccination history included: moderna (Dose Number: 1, Batch/Lot No: 012L20A, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 73-year-old, for COVID-19 Immunization; moderna (Dose Number: 2, Batch/Lot No: 013M20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 25Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; moderna (Dose Number: 3, Batch/Lot No: 039D21A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM, Route of Administration: Intramuscular), administration date: 26Oct2021, when the patient was 74-year-old, for COVID-19 Immunization. The patient had not been diagnosed with COVID-19 prior vaccination. The patient had no ill effects until Sunday, 16Oct2022. Hip pain, body ache, loss of appetite. Symptoms continued through 18Oct2022. Covid home test was negative on the 19Oct2022. Slight severity of symptoms continued. Fever started on 19Oct2022 along with SOB (shortness of breath), shaking chills, coughing, rhinitis, and joint pain. Went to urgent care and sent by ambulance to ER (emergency room). Oxygen saturation went from 97 to 90% with slow ambulation. Admitted to ER, started on IV fluids, CXR (Chest X-ray) was negative, lungs were clear, no pneumonia. Negative viral panel, normal urine, hematology, and chemistry. Repeat Covid test was negative. He was given IV Vancomycin. He was dehydrated. Nasal prongs. Blood cultures pending. Discharged at 03:30 with normal temp. At 04:45 PM, temp was 101.1 with chills. At 06:00 PM, temp was 104.5. Returned to ER via ambulance. Symptoms continuing through 26Oct2022, he continued off and on with fever, chills, body ache, headache, vomiting, diarrhea, loss of appetite, weakness, and exhaustion. The patient previously received three doses of Moderna and was administered with fourth dose of BNT162B2, BNT162B2 OMI BA.4-5 on 13Oct2022 at 12:00 which was an interchange of vaccine products. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.