Age: 61.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Burning sensation, Gait inability, Influenza like illness, Product use issue
Clinical narrative: severe burning in the right hip area / serious burning in his right hip; when he tried to walk he only got two steps and had to stop / he can't walk; mild flu like symptoms; the patient got the vaccine yesterday. She reports he also had the flu shot yesterday, but in a different arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61-year-old male patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in arm for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 08Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for influenza immunisation. The patient's relevant medical history included: "Left Hip Replacement" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu shot (no reaction from previous yearly flu shots), for Influenza immunization; COVID-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), administration date: Feb2022, when the patient was 61 years old, for COVID-19 immunization; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), administration date: Sep2021, when the patient was 60 years old, for COVID-19 immunization; COVID-19 vaccine (DOSE 1, SINGLE), administration date: Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 08Sep2022, outcome "unknown", described as "the patient got the vaccine yesterday. She reports he also had the flu shot yesterday, but in a different arm"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Sep2022, outcome "not recovered", described as "mild flu like symptoms"; BURNING SENSATION (non-serious) with onset 09Sep2022, outcome "not recovered", described as "severe burning in the right hip area / serious burning in his right hip"; GAIT INABILITY (non-serious) with onset 09Sep2022, outcome "not recovered", described as "when he tried to walk he only got two steps and had to stop / he can't walk".  Additional information: The reporter was inquiring for her brother (patient) who was having a reaction but he wouldn't go to the hospital. On 08Sep2022, the patient received the Pfizer bivalent booster dose in one arm and also the flu vaccine (manufacturer unknown) in the opposite arm. The patient gets the flu shot every year and has never had any reaction. The next morning an hour before the time of report (09Sep2022), the patient woke up with severe/serious burning in the right hip area, when he tried to walk he only got two steps and had to stop. The reporter stated the patient couldn't walk. He was also having mild flu-like symptoms. The reporter was reading and knew it could be a creatine or renal thing and it had got to be from the booster. This was the patient's third booster, however it was his first bivalent dose. The events did not require a visit to the emergency room nor a physician office. The patient had an appointment on Monday (12Sep2022) to see his doctor. The patient had no prior vaccinations within 4 weeks and did not experience any AE(s) following prior vaccinations. The patient previously had left hip replacement, but never had burning before; he was in good shape. No relevant tests were performed.  The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.