Sex: M
Vaccine: COVID19, UNK
Symptoms: Loss of consciousness, Syncope
Clinical narrative: fainted/passed out; Fainted/passed out; This is a spontaneous report received from a contactable pharmacist via a medical information team. This report is in reference to one of the patients the caller states passed out. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8729, Expiration date: 20Jul2021), via an unspecified route of administration on 06Apr2021 as a single dose for COVID-19 immunization, sodium chloride (SALINE, Formulation: Unknown, Batch number: 6023228), via an unspecified route of administration on an unspecified date at an unknown dose and frequency for an unknown indication. The patient's medical history and concomitant medications were not reported. The patient had fainted/passed out on 06Apr2021. It was reported that, vaccine coordinator said that they use the same lot number for all three of their facilities. An hour ago, at one of their facilities, he said 3 people fainted and 1 had seizure after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. HCP wants to know if there have been any reports of having these reactions associated with the specific lot number: ER8729. He said he already has 56 vials of the vaccine mixed up with the same lot and wants to know if he should still continue using it. HCP also added that out of 3,200 vaccines that they have out of the same lot, they only had 4 incidences. Pharmacist told the HCP that there was no information available about fainting and having seizures associated with the lot: ER8729. However, pharmacist told him that I would forward his concern to someone from our team for further research. Escalating to second line for further research and handling. Caller was a pharmacist who was heavily involved in the COVID-19 vaccine. He manages 3 locations and more than 1500 COVID-19 vaccine doses. Today he's reporting that at one of his other locations, administering the COVID-19 vaccine within about 20 minutes there were 4 patients with reactions. One patient had a seizure and 3 patients passed out. These patient's had just received the COVID-19 vaccine and were still being watched within the 15-minute post vaccination time. All 4 patients received the COVID-19 vaccine from the same lot number but not from the same vial. One of the patient's that passed out said that she has had some issues with vaccines in the past. Caller reports that his COVID-19 vaccine facilities are busy today giving COVID-19 vaccines and about half the people receiving the vaccine are waiting inside and about half are waiting outside. It's about 84F outside and he's reporting that he's not seeing anything to eat or drink in these individuals waiting for the COVID-19 vaccine. He believes the NDC number for the COVID-19 vaccine ends in "02". Caller did not have any information on the patients involved. The outcome of the events was unknown.  Information on Lot/Batch number was available. No further information is provided or obtained. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of syncope, loss of consciousness and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.