Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Lip blister, Off label use, Oral mucosal blistering
Clinical narrative: Hypersensitivity of mouth and taste; Hypersensitivity of mouth and taste; Eating is painful; Eating is painful; everything tastes salty; Gums are swollen and mild bleeding; Gums are swollen and mild bleeding; Tongue is painful to move; Blisters of inside lower lip, tongue and corners of the mouth; Blisters of inside lower lip, tongue and corners of the mouth; Blisters of inside lower lip, tongue and corners of the mouth; Dose 1: Moderna, Dose 2: Moderna; Dose 1: Moderna, Dose 2: Moderna; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 18:00 (Lot number: FH8028) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Essential tremor" (unspecified if ongoing), notes: other medical history: Essential tremor, hypothyroidism,, dm2, hyperlipidemia, obesity; "Hypothyroidism" (unspecified if ongoing), notes: other medical history: Essential tremor, hypothyroidism,, dm2, hyperlipidemia, obesity; "dm2" (unspecified if ongoing), notes: other medical history: Essential tremor, hypothyroidism,, dm2, hyperlipidemia, obesity; "Hyperlipidemia" (unspecified if ongoing), notes: other medical history: Essential tremor, hypothyroidism,, dm2, hyperlipidemia, obesity; "Obesity" (unspecified if ongoing), notes: other medical history: Essential tremor, hypothyroidism,, dm2, hyperlipidemia, obesity; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin, codeine. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: Penicillin, codeine. Vaccination history included: Moderna (Dose number: 2, Prev dose product=COVID 19, prev dose brand=Moderna, prev dose brand unknown=False, prev dose lot number=004M20A, prev dose lot unknown=False, prev dose administration date=25Jan2021, prev dose administration time=12:00 PM, prev dose dose number=2), administration date: 25Jan2021, when the patient was 52 years old, for COVID-19 Immunization; Moderna (Dose number: 1, prev dose product=COVID 19, prev dose brand=Moderna, prev dose brand unknown=False, prev dose lot number=039K20A, prev dose lot unknown=False, prev dose administration date=28Dec2020, prev dose administration time=10:00 AM, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 28Dec2020, when the patient was 52 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 26Nov2021 18:00, outcome "unknown" and all described as "Dose 1: Moderna, Dose 2: Moderna"; IMMUNISATION (non-serious) with onset 26Nov2021 18:00, outcome "unknown", described as "Booster"; HYPERSENSITIVITY (non-serious), TASTE DISORDER (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Hypersensitivity of mouth and taste"; EATING DISORDER (non-serious), PAIN (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Eating is painful"; DYSGEUSIA (non-serious) with onset 28Nov2021, outcome "not recovered", described as "everything tastes salty"; SWELLING (non-serious), GINGIVAL BLEEDING (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Gums are swollen and mild bleeding"; GLOSSODYNIA (non-serious) with onset 28Nov2021, outcome "not recovered", described as "Tongue is painful to move"; LIP BLISTER (non-serious), TONGUE BLISTERING (non-serious), ORAL MUCOSAL BLISTERING (non-serious) all with onset 28Nov2021, outcome "not recovered" and all described as "Blisters of inside lower lip, tongue and corners of the mouth". Therapeutic measures were not taken as a result of hypersensitivity, taste disorder, eating disorder, pain, dysgeusia, swelling, gingival bleeding, glossodynia, lip blister, tongue blistering, oral mucosal blistering.  Additional information: Patient has not taken any other vaccine in four weeks. The patient took prescription medication in two weeks. Patient reported the adverse event hypersensitivity of mouth and taste. Eating is painful and everything tastes salty. Gums are swollen and mild bleeding, especially when brushing teeth. Tongue is painful to move. Blisters of inside lower lip, tongue and corners of the mouth. All start 48 hours after booster dose and still lasting at 16 days afterwards. The patient has no covid prior to vaccination and patient has not tested covid post vaccination.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.