Age: 57.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue
Clinical narrative: ankle fracture; sympathetic nerve system issue; arm didn't go dead and this condition that developed and has him in Physical Therapy for 6 months; off label use; Product use for unapproved combination; Interchange of vaccine products; developed CRPS which is Complex Regional Pain Syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 57 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Dec2022 as dose number unknown,single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history included: "stomach bug", start date: Aug2022, stop date: Oct2022, notes: He had a stomach bug from August to October but went away. Concomitant medication(s) included: CILNIDIPINE, start date: Jan2023; IBUPROFEN. Vaccination history included: moderna coviD-19 vaccine (DOSE 1, SINGLE, Lot number: 030M20A, via an intramuscular), administration date: 06Feb2021, for COVID-19 immunisation; moderna coviD-19 vaccine (Dose 2, Single, Lot number: 026A21A, via an intramuscular), administration date: 06Mar2021, for COVID-19 immunisation; moderna coviD-19 vaccine (Dose 3 (Booster), Single, Lot number: 067F21A, via an intramuscular), administration date: 15Nov2021, for COVID-19 immunisation; moderna coviD-19 vaccine (Dose 4 (Booster), Single, Lot number: 6A8L21A could be a 64 instead of 6A, via an intramuscular), administration date: 30Mar2022, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Dec2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 06Dec2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 06Dec2022, outcome "unknown"; COMPLEX REGIONAL PAIN SYNDROME (non-serious) with onset Dec2022, outcome "unknown", described as "developed CRPS which is Complex Regional Pain Syndrome"; ANKLE FRACTURE (medically significant), outcome "unknown"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "sympathetic nerve system issue"; LIMB INJURY (non-serious), outcome "unknown", described as "arm didn't go dead and this condition that developed and has him in Physical Therapy for 6 months". The event "developed crps which is complex regional pain syndrome" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of limb injury.  Clinical course: Would be getting another update and was 9 months and precautionary. No other conditions & investigations. Caller was not diabetic or have high cholesterol or have high blood pressure which could contribute to this. This was sympathetic nerve system issue and he was healthy. He had a stomach bug from August to October but went away. Vaccination Facility Type: Clinic. No Vaccine Administered at Facility. Caller received the Bivalent COVID-19 Vaccine with the Flu shot on the same day. Manufacturer name and lot number: unknown. He had no immediate and arm didn't go dead and this condition that developed and had him in physical therapy for 6 months. His older brother is a physician and told him he should notify Pfizer. He stated that this was what it was and would still get vaccine again. He knew there wasn't any difference in changing and he wouldn't have but this was what the facility had. Other than people being a little more tired on Pfizer, he didn't expect a reaction on Pfizer. Yes prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.