Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Diarrhoea, Headache, Immunisation
Clinical narrative: Headache for a few hours; Fever starting morning of 09Dec, going up to 102 F/Still continuing on 11Dec but only up to 99.3 F; Diarrhea for a few hours; Sore and red injection site; Sore and red injection site; Swollen and sore armpit; Swollen and sore armpit; Dose_number=3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 14:30 (Lot number: 30135BA) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high triglycerides", start date: 2004 (unspecified if ongoing); "low clotting Factor VIII", start date: 2004 (unspecified if ongoing), notes: low clotting Factor VIII; "idiopathic", start date: 2004 (unspecified if ongoing), notes: in 2004, idiopathic, hasn't been tested since; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; MELOXICAM; CYCLOBENZAPRINE; UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]; CHROMIUM PICOLINATE; CENTRUM FORTE; ZINC; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]; ACIDOPHILUS. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin"; Biaxin, reaction(s): "Known allergies: Biaxin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Feb2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 14:30, outcome "unknown", described as "Dose_number=3"; PYREXIA (non-serious) with onset 09Dec2021 09:00, outcome "recovering", described as "Fever starting morning of 09Dec, going up to 102 F/Still continuing on 11Dec but only up to 99.3 F"; DIARRHOEA (non-serious) with onset 09Dec2021 09:00, outcome "recovered" (Dec2021), described as "Diarrhea for a few hours"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 09Dec2021 09:00, outcome "recovering" and all described as "Sore and red injection site"; LYMPHADENOPATHY (non-serious), AXILLARY PAIN (non-serious) all with onset 09Dec2021 09:00, outcome "not recovered" and all described as "Swollen and sore armpit"; HEADACHE (non-serious) with onset 10Dec2021, outcome "recovered" (Dec2021), described as "Headache for a few hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, diarrhoea, vaccination site erythema, vaccination site pain, lymphadenopathy, axillary pain, headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient received Tylenol as a treatment for the adverse event. Fever starting morning of 09Dec, going up to 102 F.  Still continuing on 11Dec but only up to 99.3 F. Diarrhea for a few hours just on 09Dec.  Sore and red injection site.  Swollen and sore armpit beginning late on 09Dec, still continuing on 11Dec.  Headache for a few hours on 10Dec but that was probably caffeine withdrawal. The case was reported as Non-serious. Device stamp date was reported as, 11Dec2021.  No follow-up attempts are needed; No further information is expected.