Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: left axilla discomfort; unable to palpate nodules; left work early due to GI sx; cough; injection site itching; Booster; repeated awakening during the night; extreme fatigue; chills; malaise; HA; left arm injection site tenderness; erythema; nausea; diarrhea; This is a spontaneous report received from a contactable Nurse. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 29Sep2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2019 (ongoing); "Polycythemia vera", start date: 2020 (ongoing); "rhinorrhea" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR taken for asthma, start date: 2020 (ongoing); HYDREA taken for polycythaemia vera, start date: Oct2020 (ongoing); SYMBICORT taken for asthma, start date: 2019 (ongoing); VENLAFAXINE taken for depression, start date: 2010 (ongoing); AZELASTINE HCL taken for hypersensitivity, start date: 2019 (ongoing); IPRATROPIUM taken for rhinorrhoea, start date: 2019 (ongoing); IRON taken for anaemia, start date: 2015 (ongoing); ASA taken for anticoagulant therapy, start date: 2019; NASONEX taken for hypersensitivity, start date: 2019. Vaccination history included: Bnt162b2 (Dose: 1st , Time (24hr): 0930 , Site and Route of injection, Anatomical Site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EH9899), administration date: 16Dec2020, when the patient was 63 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2nd, Site and Route of injection, Anatomical Site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EL1283), administration date: 06Jan2021, when the patient was 63 years old, for COVID-19 immunization, reaction(s): "injection site tenderness that progressed causing repeated awakening during the night", "injection site tenderness", "chills". The following information was reported: FATIGUE (medically significant) with onset Sep2021, outcome "unknown", described as "extreme fatigue"; CHILLS (medically significant) with onset Sep2021, outcome "unknown", described as "chills"; MALAISE (medically significant) with onset Sep2021, outcome "unknown", described as "malaise"; HYPERTENSION (medically significant) with onset Sep2021, outcome "unknown", described as "HA"; VACCINATION SITE PAIN (medically significant) with onset Sep2021, outcome "not recovered", described as "left arm injection site tenderness"; VACCINATION SITE ERYTHEMA (medically significant) with onset Sep2021, outcome "not recovered", described as "erythema"; NAUSEA (medically significant) with onset Sep2021, outcome "unknown", described as "nausea"; DIARRHOEA (medically significant) with onset Sep2021, outcome "unknown", described as "diarrhea"; COUGH (medically significant) with onset 01Oct2021, outcome "unknown", described as "cough"; VACCINATION SITE PRURITUS (medically significant) with onset 01Oct2021, outcome "unknown", described as "injection site itching"; LIMB DISCOMFORT (medically significant) with onset 02Oct2021, outcome "recovering", described as "left axilla discomfort"; INSOMNIA (medically significant) with onset Sep2021, outcome "unknown", described as "repeated awakening during the night"; GASTROINTESTINAL TRACT IRRITATION (medically significant) with onset 01Oct2021, outcome "recovered" (02Oct2021), described as "left work early due to GI sx"; LYMPH NODE PAIN (medically significant) with onset 02Oct2021, outcome "unknown", described as "unable to palpate nodules"; IMMUNISATION (non-serious) with onset 29Sep2021, outcome "unknown", described as "Booster". Therapeutic measures were taken as a result of fatigue, chills, malaise, hypertension, vaccination site pain, vaccination site erythema, nausea, diarrhoea, cough, vaccination site pruritus, limb discomfort, insomnia, gastrointestinal tract irritation, lymph node pain included Tylenol/lbuprofen, Benadryl 25mg, Prednisone 10mg po (oral).  The lot number for bnt162b2 was not provided and will be requested during follow up.