Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased, Myalgia, Off label use, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10May2022 at 19:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 58 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Inflammatory Bowel Disease in remission" (unspecified if ongoing). Concomitant medication(s) included: AZATHIOPRINE; DELZICOL. Vaccination history included: moderna coviD-19 vaccine (Dose Number: 1, Batch/Lot No: 027A21A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 06Mar2021, when the patient was 57-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (Dose Number: 2, Batch/Lot No: 059E21A, Location of injection: Arm Left, Vaccine Administration Time: 03:00 AM, Route of Administration: Intramuscular), administration date: 11Sep2021, when the patient was 57-year-old, for COVID-19 Immunization; moderna coviD-19 vaccine (Dose Number: 3, Batch/Lot No: 030L20A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 06Nov2021, when the patient was 58-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10May2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 10May2022, outcome "unknown"; SLEEP DISORDER (non-serious), MOBILITY DECREASED (non-serious) all with onset 11May2022 at 01:00, outcome "not recovered" and all described as "Symptoms affecting quality of sleep and general mobility i.e. acting like someone with advanced arthritis with regarding to general mobility"; ARTHRALGIA (non-serious) with onset 11May2022 at 01:00, outcome "not recovered", described as "arthralgias"; FATIGUE (non-serious) with onset 11May2022 at 01:00, outcome "not recovered"; PYREXIA (non-serious) with onset 11May2022 at 01:00, outcome "recovered" (May2022), described as "fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 11May2022 at 01:00, outcome "recovered" (May2022), described as "flu-like symptoms"; HEADACHE (non-serious) with onset 11May2022 at 01:00, outcome "recovered" (May2022); MALAISE (non-serious) with onset 11May2022 at 01:00, outcome "recovered" (May2022); MYALGIA (non-serious) with onset 11May2022 at 01:00, outcome "recovered" (May2022), described as "myalgias". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of influenza like illness, pyrexia, malaise, myalgia, headache, fatigue, arthralgia, sleep disorder, mobility decreased. Additional information: The patient had no known allergies. The patient did not received other vaccines in four weeks. The patient did not had COVID prior vaccination and has not been COVID tested post vaccination. The patient experienced flu-like symptoms first 48 hours including fever, malaise, myalgias, headache, fatigue and arthralgias. Extreme fatigue and arthralgias (generalized) continued while other symptoms resolved. COVID test taken ~7 days after vaccination was done to rule out COVID infection as cause of prolonged symptoms. COVID PCR test was negative. Symptoms affecting quality of sleep and general mobility i.e. acting like someone with advanced arthritis with regarding to general mobility. Fatigue not relieved by rest. Prolonged arthralgia and fatigue did not occur after first 3 vaccinations with Moderna vaccine. No follow-up attempts are possible. No further information is expected.