Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Lung disorder, Memory impairment
Clinical narrative: client "cannot remember"; the client is "at risk to get covid"; he had "pulmonary issues"; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 32 year-old male patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (disability) with onset 2021, outcome "unknown", described as "client "cannot remember""; EXPOSURE TO SARS-COV-2 (disability) with onset 2021, outcome "unknown", described as "the client is "at risk to get covid""; LUNG DISORDER (disability) with onset 2021, outcome "unknown", described as "he had "pulmonary issues"".   Addition information: PQC Details:  Request Name: REQ-# Product: COMIRNATY Question: Caller is a HCP. Pfizer covid 19 vaccine confirmed. Caller asked for guidance for an unique situations involving one of his clients. Caller described the client as "severely disabled" and that this client "cannot remember" if he had either dose of the vaccine. Caller said the client is "at risk to get covid" and said he had "pulmonary issues". Caller also said that the client's "medical records don't show anything" and that an address and cell phone number are needed to access the record and his "caretaker doesn't work for the county any more". Caller is asking for any available guidance on offering a vaccine dose to someone who may have already received the primary series.  Caller clarified that he is asking if there is any guidance available on administering a primary series, both first and second doses, to the an individual who has already received the primary series, approximately eight months after first primary series, including in potential adverse events? E-transmitting for potential AE. Response: Treatment disclaimer stated and emphasized.  Shared with caller information from attached document, noting that Pfizer is independent of these studies, referencing the study: solid organ transplant (SOT) recipients which investigated the use of a 3rd dose of Comirnaty. No cases of COVID-19 occurred in these patients. There were no serious adverse events (SAEs) after the 3rd dose of the vaccine and no acute rejection episodes were noted.  Upon clarification of the caller's request, escalation offered for caller.   Fulfillment package offered of information available at this time; sent. Survey offered.  The lot number for the vaccine, [COMIRNATY], was not provided and will be requested during follow up.; Sender's Comments: Based on the plausible temporal relation, the association between the events of memory impairment, exposure to SARS-CoV-2 and lung disorder and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.