Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Pharmacist wants to know if the vaccines are ok to use and if the vaccines did not get outside of the required temperature range when shipped, one patient has been administered the vaccine.; This case has been considered invalid as info not qualifying for AE as the patient had did not have any adverse events as per the FU information received.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A 20-year-old male patient received BNT162b2 (BNT162B2), on 10Oct2022 at 16:30 as dose 2, 0.3 ml single (Lot number: FP7141, Expiration Date: 30Nov2022) at the age of 20 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, 0.3 ml SINGLE; Lot number: FP7138; Expiration date: 30Nov2022; Anatomical location: Left deltoid), administration date: 30Aug2022, when the patient was 20-year-old, for COVID-19 Immunization. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 10Oct2022, described as "Pharmacist wants to know if the vaccines are ok to use and if the vaccines did not get outside of the required temperature range when shipped, one patient has been administered the vaccine.".  Additional information: Pharmacist received an email and there was an onsite monitory exemption. The email was regarding a temperature alarm with the shipment of Pfizer Covid-19 vaccines and he wants to know if the vaccines are ok to use and if the vaccines did not get outside of the required temperature range when shipped? Pharmacist mentioned one patient has been administered the vaccine in deltoid muscle.  Follow-up attempts are completed. No further information is expected.  Follow-up (31Oct2022): This is a spontaneous follow-up report from a contactable pharmacist. This pharmacist reported in response to HCP letter via follow-up letter which included that:  Updated information includes: Reporter's institute was added in slider #1, Follow-up activity possible field was updated as No due to consent denied, Suspect route of administration was added, Onset time of event was updated as per start time of suspect drug.  Additional information: Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? No If yes above, do you consider the Pfizer product had a causal effect to the adverse event? No  Patient age at vaccination: 17 years  Pfizer/Biontech COVID-19 vaccine details: Dose: 1st Date: 10Oct2022 time: about 16:30 PM Anatomical site of injection: Deltoid Route of administration: Intramuscular Lot: FP7141 Vaccination facility type: Pharmacy or Drug store 2nd Dose Vaccination facility address: Withheld Concomitant drugs: Unknown Patient's medical history: Unknown Relevant tests: None needed or done to my knowledge Adverse events: No adverse events to my knowledge Comments/Narrative: No error to my knowledge/ temperature monitor with the vaccine shipment did not turn off when sent back to the shipper. The vaccine was declared ok when we received it by the shipping company. The dose was given the day we received the vaccine after it thawed. Vaccine was received just after 9 AM, it and do thaw, so the patient came back at about 16:30 PM and received his 2nd vaccination. This was just a temperature monitor that did not shut off after the vaccine was received.