Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Fall, Muscle strain
Clinical narrative: she blacked out and had to be hospitalized; fell; she was tired; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Mar2021 14:45 (Lot number: EP6955) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sleep apnea", start date: 2002 (unspecified if ongoing); "Migraines", start date: 1985 (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Bnt162b2 (Dose: 01; lot: EN6198; Anatomical location: left arm.), administration date: 05Mar2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 28Mar2021 04:00, outcome "recovered", described as "she blacked out and had to be hospitalized"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "she was tired"; DEHYDRATION (non-serious) with onset 2021, outcome "unknown", described as "dehydrated"; FALL (non-serious) with onset 28Mar2021 04:00, outcome "unknown", described as "fell". Patient stated about the black out, stating that she, woke up at 4 am, took 2 steps, and she was down. Patient stated she was not admitted. Patient didn't received prior Vaccinations (within 4 weeks) and she got her flu shot after. Patient was like give me a break. Patient stated she did not have results to provide and stated these tests were done while she was in the ER. The events "she blacked out and had to be hospitalized", "she was tired", "dehydrated" and "fell" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: chest x-ray: (2021) unknown results; computerised tomogram: (2021) unknown results; (2021) unknown results; computerised tomogram head: (2021) unknown results; computerised tomogram neck: (2021) unknown results; echocardiogram: (2021) unknown results; full blood count: (2021) unknown results; sars-cov-2 test: (Dec2021) over 2500; troponin: (2021) unknown results; x-ray: (2021) unknown results; (2021) unknown results. Patient had a "Sars-CoV-2 test done within the last 3 days. The results just came back today and are >2500. Therapeutic measures included pumped with fluids as a result of loss of consciousness, fatigue, dehydration.  Additional information: Patient was asking for guidance in receiving the booster dose after her reaction to the second dose. It was reported that, patient should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Patient refer to speak to healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Patient did like to know the significance of this test, and if it can guide her decision to receive the booster dose. Reporter stated that they didn't find anything wrong. Patient's father was insisting she get the 3rd booster and she was not sure, maybe she was allergic to it. Patient stated that her doctor didn't want to do the test and was told they don't see any problems. Reporter stated the normal was .08 and it looks like her levels are really high. Reporter stated that 7 months later, could she have been given too much to have a 2500 level in her now. The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EP6955 was investigated. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.