Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Poor quality product administered, Product administration error, Vaccination site pain
Clinical narrative: Received the orange cap formulation of the Pfizer BioNTech COVID 19 vaccine at day 89 of being in the refrigerator instead of the 72 days allowable.; Received the orange cap formulation of the Pfizer BioNTech COVID 19 vaccine at day 89 of being in the refrigerator instead of the 72 days allowable.; patient had chills and body aches for a day or two after; patient had chills and body aches for a day or two after; tenderness at the injection site; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician) from medical information team.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 21May2022 as dose 3 (booster), 0.2 ml single (Lot number: FL8094, Expiration Date: 30Sep2022) at the age of 9 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1 , Lot: FK5127, Expiry: 28Feb2022 , Dose and Route: 0.2mL IM, left arm, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 22Nov2021, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot: FK5618, Expiry: 25Feb2022, Dose and Route: 0.2mL IM, left arm, chills and body aches for a day or two after. As well as tenderness at the injection site), administration date: 14Dec2021, for COVID-19 Immunization, reaction(s): "tenderness at the injection site", "chills", "body aches". The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 21May2022, outcome "unknown" and all described as "Received the orange cap formulation of the Pfizer BioNTech COVID 19 vaccine at day 89 of being in the refrigerator instead of the 72 days allowable."; PAIN (non-serious), CHILLS (non-serious) all with onset 2022, outcome "unknown" and all described as "patient had chills and body aches for a day or two after"; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "tenderness at the injection site".  Additional information: Registered nurse calling stated that four pediatric patients received the orange cap formulation of the Pfizer BioNTech COVID 19 vaccine at day 89 of being in the refrigerator instead of the 72 days allowable. Do these kids need to be revaccinated. Caller who is a registered nurse reports that she has 4 patients who got their COVID boosters at a local pharmacy. The pharmacy has called the patients and told them that the vaccines was given after it was expired. Caller confirms the product is COVID vaccine ages 5-11. Caller states all the patient received all their doses and then 5 months later they all got their booster. No Emergency Room, Physician Office visit but this patient's mother did mention the patient had an immune reaction after she received the 2nd and 3rd dose, the patient had chills and body aches for a day or two after. As well as tenderness at the injection site, caller said the usual stuff. The 2nd dose was back in the winter. No prior Vaccinations (within 4 weeks). The vaccine was diluted. The vaccine was stored at fridge (2-8 degrees C) when excursion occurred. It was further reported that, reporter called to follow up on a call a couple weeks ago about her patients that received expired boosters. She works in a pediatric office and a few patient's got boosters and were notified that the boosters had been in the refrigerator too long. Someone at Pfizer followed up with her, but nobody has gotten back to her about what to do. She has been in touch with people from Pfizer and was told the product exceeded the shelf life but was not told whether to revaccinate or what is the next step for the patients. The letter says Pfizer cannot advise on patient impact or revaccination. Caller needs to speak with parents about safety and whether they should get an additional booster.  Follow-up (26May2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of query. Storage temperature of vaccine when excursion occurred was confirmed.  Follow-up (09Jun2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported for a patient that: Updated information included: Primary reporter new address added and clinical course and information.  Follow-up attempts are completed. No further information is expected.  Follow-up (14Jun2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP letter [sent to physician] via follow-up letter which included that: RMH and Vaccination start date updated.  Amendment: This follow-up report is being submitted to amend previous information: added events (chills, pain, and Vaccination site pain).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200765692 Same reporter/vaccine/event, different patient;