Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Leukopenia, Mean cell haemoglobin concentration, Nausea
Clinical narrative: white blood cell count is low/ on 13Oct2022 it was 4.1 and on some current blood it was 3.3; sore arm; I felt like I was fainting/ a feel-like-fainting sensation (extreme light-headedness); a terrible headache; extreme cold (icy cold sensation); nauseous/ nausea; felt so horrible like something just came over me/ felt awful; chilled and had to sleep in different garments because she was shivering; arm was swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Feb2022 (Lot number: FJ6369, Expiration Date: 07Feb2022) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, lot FA7485,  unknown, expiration date 31Oct2021.), administration date: 04Aug2021, when the patient was 68 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, single, lot FC3184, expiration date 31Oct2021,  unknown.), administration date: 27Aug2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "The caller had the second dose and she had a reaction", "White blood cell count low". The following information was reported: LEUKOPENIA (medically significant) with onset 11Feb2022, outcome "recovering", described as "white blood cell count is low/ on 13Oct2022 it was 4.1 and on some current blood it was 3.3"; DIZZINESS (non-serious) with onset 07Feb2022, outcome "recovering", described as "I felt like I was fainting/ a feel-like-fainting sensation (extreme light-headedness)"; HEADACHE (non-serious) with onset 07Feb2022, outcome "recovering", described as "a terrible headache"; FEELING COLD (non-serious) with onset 07Feb2022, outcome "recovering", described as "extreme cold (icy cold sensation)"; NAUSEA (non-serious) with onset 07Feb2022, outcome "recovering", described as "nauseous/ nausea"; FEELING ABNORMAL (non-serious) with onset 07Feb2022, outcome "recovering", described as "felt so horrible like something just came over me/ felt awful"; CHILLS (non-serious) with onset 07Feb2022, outcome "recovering", described as "chilled and had to sleep in different garments because she was shivering"; PERIPHERAL SWELLING (non-serious) with onset 07Feb2022, outcome "recovering", described as "arm was swollen"; PAIN IN EXTREMITY (non-serious) with onset 08Feb2022, outcome "recovering", described as "sore arm". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (11Feb2022) 99/65, notes: which is normal, but it usually runs on the low end; body temperature: (11Feb2022) 97 or 97.5, notes: which is normal for her; mean cell haemoglobin concentration: (13Oct2020) 32; neutrophil count: (13Oct2020) 1.5, notes: 1.5 instead of 1.2; neutrophil count (40-68): (13Oct2020) 33.6, notes: when it should be 40-68; white blood cell count (4.5-11): (13Oct2020) 4.1, notes: instead of 4.5-11; (11Feb2022) 3.3, notes: The caller's WBC is usually low but not this low. Clinical course: The patient took her usual vitamins (unspecified). The patient received dose 3 in the shoulder, number was unknown and had an extreme cold (icy cold sensation) reported as a side effect following administration of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). Patient declined to be provided with additional information. A review of the Prescribing Information for the Pfizer-BioNTech COVID-19 vaccine did not found information regarding an extreme cold (icy cold sensation). As the Prescribing Information did not include all adverse reactions that had been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment had been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. Patient believed she was given an almost expired dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) as previously they used to put in her vaccination card the date the vaccine of expiry and it was the same dame she was administered the vaccine. Patient asked, could you please verify the expiration date on lot number FJ6369. Patient had received her primary vaccination series of the Pfizer-BioNTech COVID-19 vaccine. And had no adverse reactions to her first two doses. On Monday [07Feb2022], patient had received booster dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap), lot number FJ6369 and within minutes patient experienced some side effects: felt icy cold, nauseous and had a terrible headache. Felt like she was fainting and was extremely light-headed but that could've been because patient got up too fast, she felt so horrible like something just came over her. Patient sat on the car as it was a very strong reaction. She was feeling better on those events, however her white blood cell count was low, on 13Oct2020 it was 4.1 and on some current blood it was 3.3. Patient asked, has lower white blood cell count been reported as a side effect of the Pfizer-BioNTech COVID-19 vaccine? Some of her friends had experienced adverse events as well. Patient asked, has nausea been reported as a side effect following administration of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap)? Patient asked, has a feel-like-fainting sensation (extreme light-headedness) been reported as a side effect following administration of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap)? Patient declined to be provided with additional information. Responded as per attached pfizer-biontech covid-19 vaccine for 12 years and older formulation (purple cap) vaccine information fact sheet for recipients and caregivers about comirnaty (covid-19 vaccine, mrna) and the pfizer-biontech covid-19 vaccine to prevent coronavirus disease 2019 (covid-19) (lab-1451-17.0, revised: 31jan2022). Informed to patient, Side effects that had been reported with the vaccine include fainting in association with injection of the vaccine. A review of the Prescribing Information for the Pfizer-BioNTech COVID-19 vaccine did not find information regarding feel-like-fainting sensation (extreme light-headedness). As the Prescribing Information did not include all adverse reactions that had been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. Because your doctor/healthcare provider was most familiar with your medical condition, clinical history, how your treatment had been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take. Patient asked, "Has headache been reported as a side effect following administration of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap)?". The patient will be traveling and she will be at 5 months and got the booster. No other products received. The patient was calling about the Pfizer Biontech vaccine. The patient had the first shot which was no issue. The patient had the second dose and she had a reaction. The patient was glad to had a reaction because she typically has a low WBC. The patient had the booster dose, the third dose, on Monday and was dizzy and felt horrible and they said to wait at the office. The patient got up from the room and felt awful and sat in the car for a while and in fear of blacking out. The patient arm was swollen and so she exercised it and its less swollen today. The patient had her annual blood count today and her white blood cell count was lower than last year. Is this normal? The patient would have thought it would have been at least where it was last year. The patient got over the side effects although she isn't 100%, her arm isn't swollen and its normalizing. The patient was shocked her count went so low. The patient got the booster dose on Monday. The patient was feeling better she was chilled and had to sleep in different garments because she was shivering. The patient arm was improved but still slightly sore. The patient exercised her arm and it dissipated. She took her usual vitamins. The patient blood pressure today was 99/65 which is normal, but it usually runs on the low end. The patient temperature today was 97 or 97.5 which is normal for her. The patient WBC was usually low but not this low. The patient has been having headaches, but she has been stressed. The patient was working on herself so she should have seen an improvement. The patient clarified and confirmed that her previous labs were drawn in 2020 not 2021 as previously reported.  No follow-up attempts are possible. No further information is expected.