Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Diarrhoea, Dizziness, Dysuria, Ear pain
Clinical narrative: ringing; Itchy rash; hives; headache; vomiting; diarrhea; low blood pressure; stomach cramps; chest pain; heart palpitations; kidney pain; pain when urinating; sores in mouth on tongue; sores in mouth on tongue, in throat and nose; sores in mouth on tongue, in throat and nose; Pain when swallowing radiating to ears; Pain when swallowing radiating to ears; swelling in hand and injection arm; Pain when swallowing radiating to ears/pain in ears; dizziness; loss of balance; weakness; confusion; fever; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2021 at 08:00 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mental health" (unspecified if ongoing); "blood issue history" (unspecified if ongoing); "chronic pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "Allergies: Benadryl". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 27Aug2021, when the patient was 46-year-old, for COVID-19 immunization, reaction(s): "Ringing", "Itchy rash", "hives", "headache", "vomiting", "diarrhea", "low blood pressure", "stomach cramps", "chest pain", "heart palpitations", "kidney pain", "pain when urinating", "sores in mouth on tongue", "sores in mouth on tongue, in throat", "sores in mouth on tongue, in throat and nose", "pain when swallowing radiating to ears", "pain when swallowing radiating to ears", "swelling in hand and injection arm", "pain when swallowing radiating to ears/pain in ears", "dizziness", "loss of balance", "weakness", "confusion", "fever", "nausea". The following information was reported: RASH PRURITIC (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "Itchy rash"; ODYNOPHAGIA (non-serious), PAIN (non-serious) all with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021) and all described as "Pain when swallowing radiating to ears"; EAR PAIN (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "Pain when swallowing radiating to ears/pain in ears"; CHEST PAIN (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021); CONFUSIONAL STATE (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "confusion"; DIARRHOEA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "diarrhea"; DIZZINESS (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021); PYREXIA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "fever"; HEADACHE (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021); PALPITATIONS (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "heart palpitations"; URTICARIA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "hives"; RENAL PAIN (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "kidney pain"; BALANCE DISORDER (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "loss of balance"; HYPOTENSION (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "low blood pressure"; NAUSEA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021); DYSURIA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "pain when urinating"; TINNITUS (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "ringing"; GLOSSODYNIA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "sores in mouth on tongue"; OROPHARYNGEAL PAIN (non-serious), NASAL DISCOMFORT (non-serious) all with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021) and all described as "sores in mouth on tongue, in throat and nose"; ABDOMINAL PAIN UPPER (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "stomach cramps"; EXTENSIVE SWELLING OF VACCINATED LIMB (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "swelling in hand and injection arm"; VOMITING (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021); ASTHENIA (non-serious) with onset 30Sep2021 at 08:20, outcome "recovered with sequelae" (Oct2021), described as "weakness". The events "ringing", "itchy rash", "hives", "headache", "vomiting", "diarrhea", "low blood pressure", "stomach cramps", "chest pain", "heart palpitations", "kidney pain", "pain when urinating", "sores in mouth on tongue", "sores in mouth on tongue, in throat and nose", "pain when swallowing radiating to ears", "swelling in hand and injection arm", "pain when swallowing radiating to ears/pain in ears", "dizziness", "loss of balance", "weakness", "confusion", "fever" and "nausea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, rash pruritic, urticaria, headache, vomiting, diarrhoea, hypotension, abdominal pain upper, chest pain, palpitations, renal pain, dysuria, glossodynia, oropharyngeal pain, nasal discomfort, odynophagia, pain, extensive swelling of vaccinated limb, ear pain, dizziness, balance disorder, asthenia, confusional state, pyrexia, nausea.  Additional information: Symptoms occurred 45 minutes after first injection and lasted 1 week, symptoms occurred 20 minutes after second injection and lasted 2 weeks. Adverse event treatment included oral and injection medications. Patient recovered with lasting effects. Patient did not have covid prior vaccination. Covid was tested post vaccination. Covid test type post vaccination: Nasal Swab, Covid test result: Negative, Covid test type post vaccination: Other, Covid test name post vaccination: Saliva test, Covid test result: Negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.