Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Pain in extremity, Product use issue
Clinical narrative: my fourth one and a Flu shot together; my fourth one and a Flu shot together; do not feel well; she have a severe headache; bad migraine; when they gave me a shot it formed red; had my arm, I know it hurt, it's like round like knot and it's red; when they gave me a shot it formed red; had my arm, I know it hurt, it's like round like knot and it's red; I had what is my fourth booster but everyone told me its fifth one; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Oct2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 3, Manufacturer Unknown), for COVID-19 immunization; COVID-19 vaccine (DOSE 2, Manufacturer Unknown), for COVID-19 immunization; COVID-19 vaccine (DOSE 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Oct2022, outcome "unknown" and all described as "my fourth one and a Flu shot together"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset Oct2022, outcome "unknown", described as "I had what is my fourth booster but everyone told me its fifth one"; MIGRAINE (non-serious) with onset Oct2022, outcome "unknown", described as "bad migraine"; MALAISE (non-serious) with onset Oct2022, outcome "unknown", described as "do not feel well"; HEADACHE (non-serious) with onset Oct2022, outcome "unknown", described as "she have a severe headache"; ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Oct2022, outcome "unknown" and all described as "when they gave me a shot it formed red; had my arm, I know it hurt, it's like round like knot and it's red". Therapeutic measures were taken as a result of malaise, headache, migraine, erythema, pain in extremity.  Additional information: Patient had fourth dose (unspecified vaccine) before yesterday (13Oct2022) and she mentioned that she had a severe headache and side effects. She was asking as well if those side effects happened to other patient. Patient didn't want to ask question, she did not feel well. She had what was her fourth booster but everyone told her it's fifth one so, she didn't even know but she knew it's her fourth one and a Flu shot (unspecified Flu Shot) together not yesterday but day before (13Oct2022) and she had such a bad headache that no matter what she took, not even narcotic (unspecified product) or regular paracetamol (TYLENOL), she didn't know it's not going away, it's like literally bad migraine and when they gave her a shot it formed red. She asked if it was a normal side effect. It's the booster number 5 but for her it's her 4th vaccine. She did not know the name what name was that. She was in the hospital for month (not clarified). She had her arm, she knew it hurt, it's like round like knot and it's red and she asked if bad headache was normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.