Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of consciousness
Clinical narrative: First Dose: felt like she was going to pass out, but no problems breathing; First Dose: Headache; First Dose: Chills; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (ongoing), notes: High Blood Pressure. Concomitant medication(s) included: HYDROCHLORZIDE taken for hypertension (ongoing). Vaccination history included: Measles vaccine (she was 19, she had a rash and fever for 3 weeks, starting the day after the vaccine, Date: Unknown it was 40 Years Ago, Almost 50 Years, NDC, Lot, Expiration: Unknown), when the patient was 19 years old, reaction(s): "Fever", "Rash"; Small pox (she was in the health clinic for 6 days with a reaction to the Small Pox doses, Dates: Unknown, NDC, Lot, Expiration: Unknown), reaction(s): "reaction"; Herpes (horrible cold sores), reaction(s): "horrible cold sores"; Herpes (did blood work for her physical and her hematocrit was low so she had to take Iron 3 times a day because she did not have enough RBC.), reaction(s): "hematocrit was too low". The following information was reported: CHILLS (non-serious) with onset 05Feb2021, outcome "recovered", described as "First Dose: Chills"; HEADACHE (non-serious) with onset 05Feb2021, outcome "recovered" (07Feb2021), described as "First Dose: Headache"; LOSS OF CONSCIOUSNESS (medically significant) with onset 05Feb2021, outcome "recovered", described as "First Dose: felt like she was going to pass out, but no problems breathing".  Clinical course: Vaccine administered at private facility was not reported. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Caller stated they asked her if she wanted the pneumonia vaccine but she said she wanted to wait and she was glad she did. The AE's did not require a visit to emergency room and physician office. The patient did not receive any other vaccines within four weeks prior to the vaccination. Caller stated with the First Pfizer COVID Shot, within a few hours, she felt like she was going to pass out, but she had no problems breathing. Caller stated she also had a headache for two days and chills. Caller stated it started the afternoon of 05Feb2021. AE(s) following prior vaccinations reported as she did had an even worse case of herpes in college when she was in nursing school her sorority gave blood all of the time, and they used to drop the thing in and it would tell if you could give blood, well her haematocrit was too low but she gave blood anyway. Caller stated they did blood work for her physical and her haematocrit was low so she had to take Iron 3 times a day because she did not have enough RBC. She broke out with horrible cold sores. She was in a project where they gave pricks of the Small Pox Vaccine starting with 5 then 10 for a 12 week series at withheld and they continued to work up to 60 pricks of the Small Pox vaccine.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. 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.