Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, Off label use
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a patient. This is report one of two. Patient is client of caller. A 47-year-old male patient received (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 13-Apr-2021 as DOSE 3 (Age at vaccination 47-year-old), SINGLE for COVID-19 immunisation; COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE), via an unspecified route of administration from 19-Aug-2021 at 16:15 (Batch/Lot Number: 017C21A; Expiration Date: 19-Oct-2021) on 19-Aug-2021 at 16:15, at DOSE NUMBER UNKNOWN, 0.5 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine received as (BNT162B2, Batch/Lot number ER2613) via an unspecified route of administration on 22-Mar-2021 as DOSE 1 and Dose 2, SINGLE for COVID-19 immunisation. On 13-Apr-2021, The patient experienced two doses on one day in 22-Mar2-021 and a third dose 13-Apr-2021 and patient administered Moderna vaccine after the Pfizer COVID 19 on 19-Aug-2021 at 16:15. Warm transfer with Pfizer Medical Information INT-Withheld Call was transferred from (withheld) with Pfizer Customer Service. Pharmacist reporting, she had a patient who received three doses of the Pfizer COVID 19 vaccine: two doses on one day in 22-Mar-2021 and a third dose 13-Apr-2021. Reports yesterday the patient came to the pharmacy and the patient stated he had not had a COVID vaccination, so the pharmacist administered another dose of the Moderna COVID 19 vaccine. Caller confirmed information provided by transfer agent. Provides information on the Pfizer vaccinations from a database they can access. When ask for seriousness of these events caller rates them medially significant. When ask for causality, caller states no, unrelated. Adds the patient's wife came in and it is the same exact story with her. She had the same vaccinations on the same days as her husband. A clone report is created to document the wife's experience. Call was transferred by Pfizer Customer Service. Call warm transferred to Agent: Potential AE duplicate. E-transmitting AE report for review. Caller reported that one patient received 3 doses of the Pfizer COVID-19 vaccine. The 47-year-old male patient received 2 doses of the Pfizer BioNTech COVID-19 vaccine last 22-Mar-2021 and the third dose on 13-Apr-2021. The patient according to the caller "came to their pharmacy yesterday and they only ha Moderna". Caller stated that "the patient informed them that he had not previously received any COVID-19 vaccine". The patient as stated by caller wanted to know if they should receive another dose of Moderna. Caller wanted to know if there is any information on mixing the 2 brands of vaccine. Disclaimer provided. Spoke from attached document. The CDC's Advisory Committee on Immunization Practices (ACIP) provides recommendations regarding the routine administration of vaccines to children and adults. The ACIP has released interim clinical considerations for the use of Pfizer-BioNTech COVID-19 Vaccine. Regarding interchangeability of COVID-19 vaccines, the following is stated: Any currently FDA-authorized COVID-19 vaccine can be used when indicated; ACIP does not state a product preference. However, COVID-19 vaccines are not interchangeable. For mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna): Data on the safety and efficacy of a mixed-product series have not been evaluated. Both doses of the series should be completed with the same product. In exceptional situations in which the mRNA vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series. In situations where the same mRNA vaccine product is temporarily unavailable, it is preferable to delay the second dose (up to 6 weeks) to receive the same product than to receive a mixed series using a different product. If two doses of different mRNA COVID-19 vaccine products are administered in these situations (or inadvertently), no additional doses of either product are recommended at this time. Such persons are considered fully vaccinated against COVID-19 = 2 weeks after receipt of the second dose of an mRNA vaccine." Sent document via email as preferred by caller. Survey not offered as caller was warm transferred. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events off label use, Extra dose administered, Interchange of vaccine products and the administration of the vaccine cannot be excluded.