Age: 61.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: body aches; Diarrhea; Heartburn; Chills; Fever; Headache; received the Pfizer bivalent vaccine orange top, supposed to be for 5 to 11 year old's and was not diluted; heart was beating weird; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Dec2022 as dose 5 (orange cap; booster), 30 ug single (Lot number: GJ3274) at the age of 61 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose:, Regular Pfizer vaccine, caller not sure what specific name for the vaccine., Date: 30Jun2021, NDC number, lot number, expiration date: EN6205), administration date: 30Jun2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (2nd dose:, Regular Pfizer vaccine, caller not sure what specific name for the vaccine., Date: 31Jul2021, NDC number, lot number, expiration date: EW0150), administration date: 31Jul2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (3rd dose:, Regular Pfizer vaccine, caller not sure what specific name for the vaccine., Date: 02Dec2021, NDC number, lot number, expiration date: FG3527), administration date: 02Dec2021, when the patient was 60-year-old, for COVID-19 immunization; BNT162b2 (4th dose:, Regular Pfizer vaccine, caller not sure what specific name for the vaccine., Date: 09Jun2022, NDC number, lot number, expiration date: FM9992), administration date: 09Jun2022, when the patient was 61-year-old, for COVID-19 immunization.  The following information was reported: HEART RATE IRREGULAR (non-serious) with onset 10Dec2022, outcome "unknown", described as "heart was beating weird"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 10Dec2022, outcome "unknown", described as "received the Pfizer bivalent vaccine orange top, supposed to be for 5 to 11 year old's and was not diluted"; CHILLS (non-serious) with onset 11Dec2022 at 02:45, outcome "recovered" (12Dec2022); PYREXIA (non-serious) with onset 11Dec2022 at 02:45, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 11Dec2022 at 02:45, outcome "recovering"; DYSPEPSIA (non-serious) with onset 11Dec2022 at 02:45, outcome "unknown", described as "Heartburn"; DIARRHOEA (non-serious) with onset 12Dec2022, outcome "unknown", described as "Diarrhea"; PAIN (non-serious), outcome "unknown", described as "body aches". Therapeutic measures were taken as a result of headache.  Additional information: Calling about the Pfizer bivalent vaccine, caller got the vaccine on Saturday and after caller got the vaccine, which was caller's 5th one in the series, the last one, heart was beating weird, has a fitness tracker, didn't feel anything, but had a FitBit on and heart was going up and down. Then had heartburn and then went to sleep and woke up around 2 in the morning with chills, 100 degree fever, and headache Saturday. Had no adverse reactions to any of the other doses. Fever is down, still has headache but headache is a little better. What happened was the pharmacist who gave the shot called and told caller that pharmacist made a mistake and gave caller the vaccine from the orange top vial, that is supposed to be for children and is supposed to be diluted but pharmacist didn't dilute the vaccine, gave caller the full strength and did not dilute, gave caller 30mcg which was the proper amount. Never got a reaction from the prior vaccines. Received the Pfizer bivalent vaccine orange top on 10Dec2022, about 12 noon got the shot. Supposed to be for 5 to 11 year old's and was not diluted and is supposed to be diluted. Did have some diarrhea also. On 10Dec2022, immediately after came home from getting vaccine noticed heart rate going up and down. Stop date of adverse event: Unknown, has not noticed if ongoing, has not noticed, was making caller nervous and caller was not feeling anything. Then at 2:45AM in morning on 11Dec2022, got chills, fever, headache, and heartburn. Still has fever and headache. Chills: Stop date of adverse event: 12Dec2022, as of now does not have chills, has not had again. Fever: Stop date of adverse event: Seems to be gone right now, seems to have been gone. Headache: Has lingering headache still. Outcome of event: Thinks improved, on and off and has been taking Tylenol but took Tylenol last at 11 o'clock in morning so Tylenol ran out because last time caller took the Tylenol was at 11 o'clock, if shakes head feels like has headache. Diarrhea: Start date of adverse event: Just got today, does not remember if occurred before. Stop date of adverse event: Was really 1 loose movement a couple of hours ago. Not that hungry, was not eating much because of fever. Products: Confirmed this, Pfizer bivalent vaccine orange top, was caller's 5th total dose. Confirmed all 4 prior doses caller had were the regular Pfizer vaccine, caller not sure what specific name for the vaccine for 4 prior doses, isn't there just one? Hard to read vaccination card. 5th dose: Pfizer bivalent vaccine orange top, Date: 10Dec2022, Dose amount, route: Thinks 30mcg. Indication: Just wanted to take the vaccine. Consumer stated, "I had called before because, I start from the end then I will go back I got my Pfizer Bivalent vaccine (Clarified as Pfizer COVID-19 vaccine) this Saturday and I just got a call from the pharmacist and the pharmacist said to me he made mistake he gave me the vaccine from the orange cap vial instead of the grey cap vial and he gave it to me undiluted 30 micrograms or something like that and he claims that is the same as he has given it to me from the grey vial the adult Vial I just want to say that this is the Fifth vaccine I had first four had no side effects at all this one as soon as I got the vaccine (Pfizer COVID-19 vaccine) I do not know my heart was jumping up and down my question is this if the two vials are the same the orange and the grey but you have to dilute the grey one I mean the orange one why because it come into two colored Vials if they both exactly the same thing but you have to dilute one of them why is it two colors caps if they are exactly the same?" Consumer was informed about the role of Pfizer drug safety. Caller stated she called yesterday but she's been thinking about something else, so she wanted to follow up. She went in to get a dose of the Pfizer Bivalent vaccine and her pharmacist called and said "he accidentally gave me, took the orange cap vial, which is the kids vial, and he gave me that dose, but he did not dilute it. And he claims that he's pretty sure that it's the same dose as the adult dose because the adult dose does not have to be diluted and the kids' dose has to be diluted. So, I was just thinking about that. I was just thinking about the concentration of the solution and why would there be an orange vial and a gray vial if they're both exactly the same thing except one has to be diluted? Like I'm just wondering the concentrations are exactly the same prior to dilution." "I know one technically would have to be diluted because kids are supposed to get less but what I'm saying is why can't they just take the gray vial and dilute it for kids If its the same exact thing? Why do they need two colored vials? I just want to make sure I got the right amount. That I didn't get too much or too little." Caller confirmed she received the orange top bivalent as her booster instead of the gray cap bivalent."And I had a lot of side effects this time that I did not have the last time or any of the other times." "Because I just thought it was weird that I've had 4 prior vaccines and I had absolutely no side effects and this time I had very bad side effects. I had it Saturday and I still have a headache. And I had fever and chills so I thought that was odd. And body aches." Caller and her husband received the bivalent orange cap COVID-19 vaccine undiluted by mistake instead of receiving the gray cap vaccine on Saturday. They received 0.3 (didn't specify if this was in mL or mcg), their pharmacist indicated that this administration is equivalent (receiving the orange cap dose undiluted vs receiving the gray cap dose diluted). No additional details were asked since near the end of the call she mentioned to be an attorney and said that she "didn't want to have to sue Pfizer". Her husband was also on the line with her.