Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic
Clinical narrative: Atopic dermatitis; The initial case was missing the following minimum criteria: specific number of patients. Upon receipt of follow-up information on 11Apr2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 7-month-old female patient received BNT162b2 (BNT162B2), on 11Nov2022 as dose 2 (maroon cap), single (Lot number: FT9142, Expiration Date: 28Dec2022) at the age of 7 months intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE, Date: 21Oct2022, Anatomical site of injection: Left thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142, Expiration Date: 28Dec2022), administration date: 21Oct2022, when the patient was 6-month-old, for COVID-19 immunization. The following information was reported: DERMATITIS ATOPIC (non-serious) with onset 28Dec2022, outcome "unknown", described as "Atopic dermatitis".  Additional information: The reporter stated that there was an audit and they found that there were doses that they gave to patients that were used beyond its use date. Reporter verified that one lot of FT9142 was administered for two batches of that same lot number as provided by transferring agent. Two patients received two of the vaccines Beyond use date. Both patients received FX5095 BUD for their first vaccine and BUD with lot FT9142 for their second vaccine. The reporter confirmed that vials were unpunctured prior to the administration of the vaccines. The caller stated she called before regarding 49 doses of the Pfizer Covid-19 vaccine that were given patients past the beyond-use-date. It was 49 doses but 47 patients, because two patients received 2 doses with the products that were past the beyond use-date. She stated they received 3 packets that require to be filled out but it looks like it is one packet per patient. She wanted to know if she should copy these forms for all 47 patients or if they only needed information on 3 patients. Upon Follow-up on 03May2023, Reporter stated, "I have a caller on the line, she is calling about the Pfizer COVID Vaccine all formulations, she has called before because 47 patients were given the vaccines after the beyond use date and they received a packet from drug safety but only received 3 packet and she have some questions about how to fill that out if she has so many patients only got 3 packet." When paraphrased the concern: And she has 47 patients but they were only given 3 packets of 47 patients. She did say it was 49 doses because 2 of the patients received 2 doses but she is not calling to report. Reporter stated, "I have the LOT numbers of the beyond use day and the dates they were given I don't have much information on hand right now. I already had called regarding these. I have FT9142 and it was 5 patients and then it is GK1657 9 patients. The paper work that I received do I also need to provide their names and birth dates on there too. My question is because of the packets that I received if I have to submit their information on mail do I have to give it to you by phone right now because it is 47 patients. I just wanted to see if on the paper work I have to submit their information. Reporter was informed to write all patient details and sent it back to Pfizer. Upon follow up on 23May2023, it was reported that 5 Patients received Lot FT9142, none received FX5095 as the 1st dose. Upon follow-up on 22Jun203, third Covid vaccine (Dose 3, Date: 06Jan2023, Anatomical site of injection: Left thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142) was given after the beyond use date. Specific relevant test for thromboembolic events with thrombocytopenia was reported as none.  Follow-up (03May2023): This is a spontaneous follow-up report received from the same contactable Other HCP. This Other HCP reported for a patient that: Updated information included: Additional information.  Follow-up (23May2023): This is a spontaneous follow-up report from the same contactable Other HCP. Updated information Included: Historical vaccine lot number and Expiration Date, Suspect vaccine Expiration Date, Vaccine facility information and additional Information.  Follow-up (21Jun2023): Follow-up attempts are completed. No further information is expected.  Follow-up (22Jun2023): This is a spontaneous follow-up report from the same contactable Other HCP. This Other HCP reported in response to HCP letter sent included that: Updated information Included: reporter information, patient information, historical vaccine added, vaccine information, anatomical location. New event Atopic dermatitis was captured. Event onset date added. The events poor quality vaccine administered, and product administration error were deleted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300150037 same reporter and event, different patient and drug formulation;US-PFIZER INC-202300151563 same reporter and event, different patient and drug formulation;