Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, Pyrexia
Clinical narrative: chills; headache; he inadvertently gave me the vial in the orange cap that was non diluted and was supposed to be for kids and diluted but he gave me the non-diluted amount; he inadvertently gave me the vial in the orange cap that was non diluted and was supposed to be for kids and diluted but he gave me the non-diluted amount; he inadvertently gave me the vial in the orange cap that was non diluted and was supposed to be for kids and diluted but he gave me the non-diluted amount; heartrate was going up and down on my fitbit; heartburn; had a fever that was 100; migraine; had a little diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose number unknown (orange cap; booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 10Dec2022, outcome "recovered" (Dec2022), described as "had a fever that was 100"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 10Dec2022, outcome "unknown" and all described as "he inadvertently gave me the vial in the orange cap that was non diluted and was supposed to be for kids and diluted but he gave me the non-diluted amount"; DYSPEPSIA (non-serious) with onset 10Dec2022, outcome "unknown", described as "heartburn"; HEART RATE ABNORMAL (non-serious) with onset 10Dec2022, outcome "unknown", described as "heartrate was going up and down on my fitbit"; CHILLS (non-serious) with onset 11Dec2022, outcome "recovered" (Dec2022); HEADACHE (non-serious) with onset 11Dec2022, outcome "not recovered"; DIARRHOEA (non-serious) with onset Dec2022, outcome "unknown", described as "had a little diarrhea"; MIGRAINE (non-serious) with onset Dec2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was asking if it was a multi dose vial, when patient received the dose that one dose could it have been measured wrong and patient was asking if patient was given the wrong dose or does the whole vial equal one dose. Patient also asked if gray cap is a multi-dose vial as well. Patient got the Pfizer bivalent vaccine on Saturday (10Dec2022) and after patient got the vaccine when patient got home it looked like patient'd heartrate was going up and down on the fitbit and patient got heartburn and that night patient had a fever that was 100 the next morning, chills and headache. Patient still have the headache and today (date of the report) patient also had a little diarrhea. Patient never had a reaction to the other ones. The chills and fever were gone at the time of report. Patient just got a call from the pharmacist who gave the vaccine. He said, he inadvertently gave the patient the vial in the orange cap that was non diluted and was supposed to be for kids and diluted; but he gave patient the non-diluted amount. He said, it was the correct amount anyway of 30mcg, patient was concerned and wanted to make no sure that she would be ok and that he was right that it was the same dose. Patient had not gotten a migraine in a month and then patient got a headache when patient got the fever.  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.