Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Inappropriate schedule of product administration, Insomnia, Lymphadenopathy, Off label use
Clinical narrative: Acute Respiratory; hard to speak & Breathe at once; hard to speak; Pain in legs; hard to walk; change in taste; Acute pansinustis; Acute Bronchitis; no sleep; no appetite; sporadic low fever; chills; Extreme knee pain; lymph glands swollen; 1st dose:12Apr2021:2nd dose:08Aug 2021; 1st dose:12Apr2021:2nd dose:08Aug 2021; itch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Aug2021 12:00 (Lot number: FA7484) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Cough" (unspecified if ongoing); "Angiodema" (unspecified if ongoing); "Extensive FMS" (unspecified if ongoing); "Extensive CF" (unspecified if ongoing); "allergies: Multiple meds" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Gycol-peg, reaction(s): "Allergies: Gycol-PEG". Vaccination history included: Bnt162b2 (Dose:1, lot number:EP7533, administration time=12:00PM, vaccine location: right arm), administration date: 12Apr2021, when the patient was 72 years old, for COVID-19 immunization, reaction(s): "bruising", "shaky", "dizzy", "anxiety", "rash", "Burning skin", "ER Pain in Abdomen", "intense bi-lateral muscle, joint pain", "intense bi-lateral muscle, joint pain", "explosive digestive issues", "falling backwards", "vision-slow motion", "cognition issues", "itch", "fever", "chills", "nausea", "inflamation", "confusion - bad injection site clinic". The following information was reported: OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 08Aug2021, outcome "unknown" and all described as "1st dose:12Apr2021:2nd dose:08Aug 2021"; RESPIRATORY DISORDER (non-serious) with onset 10Aug2021, outcome "unknown", described as "Acute Respiratory"; DYSPNOEA (non-serious) with onset 10Aug2021, outcome "recovered" (10Aug2021), described as "hard to speak & Breathe at once"; SPEECH DISORDER (non-serious) with onset 10Aug2021, outcome "recovered" (10Aug2021), described as "hard to speak"; PAIN IN EXTREMITY (non-serious) with onset 10Aug2021, outcome "unknown", described as "Pain in legs"; GAIT DISTURBANCE (non-serious) with onset 10Aug2021, outcome "unknown", described as "hard to walk"; TASTE DISORDER (non-serious) with onset 10Aug2021, outcome "unknown", described as "change in taste"; SINUSITIS (non-serious) with onset 10Aug2021, outcome "unknown", described as "Acute pansinustis"; BRONCHITIS (non-serious) with onset 10Aug2021, outcome "unknown", described as "Acute Bronchitis"; INSOMNIA (non-serious) with onset 10Aug2021, outcome "unknown", described as "no sleep"; PRURITUS (non-serious) with onset 08Aug2021, outcome "unknown", described as "itch"; DECREASED APPETITE (non-serious) with onset 10Aug2021, outcome "unknown", described as "no appetite"; ARTHRALGIA (non-serious) with onset 08Aug2021, outcome "unknown", described as "Extreme knee pain"; LYMPHADENOPATHY (non-serious) with onset 08Aug2021, outcome "unknown", described as "lymph glands swollen"; PYREXIA (non-serious) with onset 10Aug2021, outcome "unknown", described as "sporadic low fever"; CHILLS (non-serious) with onset 10Aug2021, outcome "unknown", described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had not taken other vaccine in four weeks. The patient had taken other medications in two weeks. Was seen at site clinic. She tried to ask for Gycol. Rushed through. Had acute Bronchitis, unspecified organism. No covid prior vaccination. The patient was not tested for covid post vaccination. Device timestamp was reported as 06Oct2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101336776 same reporter/patient/product, different dose/event.