Sex: F
Vaccine: COVID19
Symptoms: Headache, Poor quality product administered, Product storage error, Product temperature excursion issue, Vaccination site pain
Clinical narrative: after getting her second dose of the Pfizer BioNtech covid 19 vaccine on 13Aug2021 was just notified 5 weeks later that the dose was not stored properly and she needs to come in for a repeat dose; 12 y/o female who received 2 doses of Pfizer-Biontech Covid19 vaccine that experienced temperature excursions before administration; headache; vomiting; arm soreness at the injection site; after getting her second dose of the Pfizer BioNtech covid 19 vaccine on 13Aug2021 was just notified 5 weeks later that the dose was not stored properly and she needs to come in for a repeat dose; 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 12 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Aug2021 17:40 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (The first Lot number is, I guess so it's an ER8731, My daughter administered your Pfizer vaccine on 23Jul2021 at 05:00 PM in left arm), administration date: 23Jul2021, for Covid-19 Immunization, reaction(s): "temperature excursion", "Poor quality vaccine administered". The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 13Aug2021, outcome "unknown", PRODUCT STORAGE ERROR (non-serious), outcome "unknown" and all described as "after getting her second dose of the Pfizer BioNtech covid 19 vaccine on 13Aug2021 was just notified 5 weeks later that the dose was not stored properly and she needs to come in for a repeat dose"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown", described as "12 y/o female who received 2 doses of Pfizer-Biontech Covid19 vaccine that experienced temperature excursions before administration"; HEADACHE (non-serious) with onset 14Aug2021, outcome "recovered" (15Aug2021), described as "headache"; VOMITING (non-serious) with onset 14Aug2021, outcome "recovered" (15Aug2021), described as "vomiting"; VACCINATION SITE PAIN (non-serious) with onset 14Aug2021, outcome "recovered" (15Aug2021), described as "arm soreness at the injection site". Therapeutic measures were taken as a result of headache, vaccination site pain.  Additional information: Reporter's daughter was administered Pfizer vaccine on 23Jul2021 and again on 13Aug2021. I was just informed both her vaccines were affected. The first dose apparently had a temperature excursion and the 2nd dose was kept in the freezer for 17 days Unbelievable with 2 mistakes administering your vaccines into a 12 year old! My daughter had a headache, vomiting and arm soreness at the injection site about 24 hours after the second dose. She explained vaccine provider would not provide information. She also noted that product went out of expiration over a few months, involved a couple of thousand people and with certain lot numbers. She goes on to explain there are liability issues. She clarified in call this is not Pfizer's problem and that the # store is to blame. Caller notes that her daughter is being followed by her pediatrician. She is asking if we have any info on the excursion experienced with the dose of the Pfizer Covid 19 Vaccine that was in the freezer for 17 days and is there anything that Pfizer can do? Reporter also explained that her Pediatrician has discussed antibody testing with her. Consumer would like to know if there was any information on antibody testing and immunity from the Pfizer Covid 19 vaccine. Patient did not have any prior vaccination, No concomitant medications and lab test were reported. No specific relevant test for thromboembolic events with thrombocytopenia. Informed by (Pharmacy name) district manager 9 wks after 1st dose that 1st dose was frozen, thawed frozen 5 times. She told me 2nd dose was left in the freezer post the BUD. They failed to properly store handle then administered the effected vaccines into my 12 year old daughter then failed to notify us in a timely manner and especially because of the recommended time allowed between doses. They aren`t sure if she recovered viable vaccine said to revaccinate with 2 more doses.   No follow-up attempts are possible. No further information is expected.