Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Investigation, Product administered to patient of inappropriate age
Clinical narrative: upper left chest pain; heart burn; got their Pfizer Covid shots and flu shots, her 8 year old got hers on Friday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 8 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 05Nov2021 11:00 (Lot number: FK5127) at the age of 8 years as dose 1, single for COVID -19 immunization; influenza vaccine (FLU VACCINE VII), administration date 05Nov2021 14:00 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 05Nov2021 11:00, outcome "unknown", described as "got their Pfizer Covid shots and flu shots, her 8 year old got hers on Friday"; CHEST PAIN (non-serious) with onset 05Nov2021 11:15, outcome "unknown", described as "upper left chest pain"; DYSPEPSIA (non-serious) with onset 05Nov2021 11:15, outcome "unknown", described as "heart burn". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Caller is a consumer asking if coughing is a possible AE with the Pfizer Biontech COVID19 vaccine. Caller noted that the lot number for her two children (8 and 11 years old) was the same even if they were administered four days apart. Caller added that the dose for her children was pre-drawn in the syringe so she asked for the bottle and took a picture of it. In addition to that, caller noticed that the lot number for her booster is different from her children but she figured it might be because her children has the vaccine with orange cap. Caller wants to know if group of vials can have the same lot number. DSU: E-transmitting duplicate AE Response: Spoken from my knowledge as a pharmacist that a batch of vials would have same lot number and that it does not mean a single vial would have different lot number from each other as distinct from the rest. Reporter Details: Caller states she is a scrub tech. The report 1 of 3 on callers 8 year old daughter. Caller states that since this is being recorded hopefully it will get to somebody, going through 3 minutes of nonsense recording is really ridiculous, we either have live agents or we don't. Caller states she has 2 kids that got their Pfizer COVID shots and flu shots, her 8 year old got hers on Friday. States that the school nurse just called saying she is complaining of chest pain, that she got her Pfizer COVID shot and flu shot on 05Nov2021 and caller got a text at 11:15am today saying that she is complaining of upper left chest pain and does she get heart burn, her lungs are clear and her vitals are stable and that she would recommend notifying her doctor of the pain. States she also felt like she had trouble breathing and the nurse didn't observe any trouble breathing and her oxygen and vitals are good. Caller states that she herself can relate to the shortness of breath, it's like you pause to take a breath. Caller states they all got the vaccines done at the health department and when she went to school you show the patient the bottle of the vaccine and draw it up in front of you and when the younger one went on Friday she asked the nurse to watch her draw it up and make sure it was right. Caller states the nurse said it was already pre drawn up so that was pretty disturbing and then this. Caller wants to know if group of vials can have the same lot number. Caller states that at the health department they are pre drawn up and the 3 people that got the COVID vaccine have complications. Caller states that the paper says to call if you have problems. Prescribing Healthcare Professional Info: caller declines to provide contact details. States she would like to be contacted and can get the information. Caller does not have NDC or expiry to provide. Caller does not have dose to provide and states that is the problem and why she wanted it drawn up in front of her but they told her they were pre drawn. Prior Vaccinations (within 4 weeks): none. Caller states say for example they get a lot number on bottles and they get a shipment of 50 bottles in a box, do they all have the same lot number States that got hers on 05Nov2021 and her lot number FK5127 is the same as her brother that got it on a different day but not the same as the callers booster lot number. Caller states she has a picture of the bottle. Caller states she is looking on the list of possible side effects and she doesn't see one for the coughing, she doesn't know if that is a side effect and why she didn't call before.  Follow-up attempts are completed. No further information is expected.