Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Investigation, Pain, Pyrexia, SARS-CoV-2 test, Tremor
Clinical narrative: never been this sick in her life; shaking; Weight started at 196, but when she weighed herself 2 days ago , it was 190; Cough; chills; Fever; Loss of appetite; Body aches; Headache; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 49-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 at 18:00 as dose 4 (booster), single (Lot number: GJ6738) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (1st dose 14Jan2021 , Lot EH9999, expiration 14Jan2021. Says 16:00 but she got in the morning, thinks that is the time it expired), administration date: 14Jan2021, when the patient was 47-year-old, for Covid-19 immunization; BNT162b2 (2nd dose 03Feb2021, Lot EL9262, expiration is 03Feb2021 at 14:00 but she got it at 10:25, so it was not expired.  Injected in right arm), administration date: 03Feb2021, when the patient was 47-year-old, for Covid-19 Immunization; BNT162b2 (3rd (Booster) dose, 01Dec2021, Lot FJ1620, expiration unknown, injected in right arm.), administration date: 01Dec2021, when the patient was 48-year-old, for COVID-19 Immunization; Flu vaccine (She had flu vaccine, but that was in Sep 2022, which was more than 4 weeks prior to this.), administration date: Sep2022, when the patient was 49 years old, for immunisation. The following information was reported: PAIN (medically significant) with onset 02Dec2022, outcome "not recovered", described as "Body aches"; PYREXIA (disability) with onset 02Dec2022, outcome "not recovered", described as "Fever"; HEADACHE (disability) with onset 02Dec2022, outcome "not recovered"; DECREASED APPETITE (medically significant) with onset 02Dec2022, outcome "not recovered", described as "Loss of appetite"; CHILLS (disability) with onset 02Dec2022, outcome "not recovered"; COUGH (disability) with onset 14Dec2022, outcome "not recovered"; ILLNESS (disability), 12 days 6 hrs after the suspect product(s) administration, outcome "unknown", described as "never been this sick in her life"; TREMOR (disability), outcome "unknown", described as "shaking"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "Weight started at 196, but when she weighed herself 2 days ago , it was 190". The patient underwent the following laboratory tests and procedures: annual physical: (Nov2022) All good and labs good, notes: 3 weeks ago; SARS-CoV-2 test: (13Dec2022) Negative, notes: she had a COVID-19 test and was negative; Weight: (unspecified date) 196, notes: Weight started at 196, but when she weighed herself 2 days ago , it was 190; (13Dec2022) 190, notes: Weight started at 196, but when she weighed herself 2 days ago , it was 190; White blood cell analysis: (Nov2022): No indication that white blood cell showed any infection, notes: 3 weeks ago. Therapeutic measures were taken as a result of headache, cough, chills, pyrexia, decreased appetite, pain, illness, tremor, weight decreased.  Clinical course: Received call from patient regarding the Pfizer Bivalent COVID vaccine booster. She is having an overreaction. She received it on 01Dec2022. Starting on 02Dec2022, she began having headache, body aches, chills, fever, loss of appetite and this has been daily since that day until today. She is supposed to be at work now and cannot. It is all through night. This has been going on since 02Dec2022. Monday, she tried to go to work and by 11am, she could not handle it anymore. She took Tylenol. Was shaking all over the place. She is concerned because last night, began with dry cough and never been this sick in her life. 3 weeks ago, did annual physical and it was all good and labs good. No indication that white blood cell showed any infection. She wants to know why after 2 weeks, she is still having this. She is the bread winner for her children. If she cannot work, she cannot earn any money. She needs some help and explanation. She contacted the (place name withheld) and they told her it was an over reaction to the vaccine. Weight started at 196, but when she weighed herself 2 days ago, it was 190. Had loss of appetite and not eating. She scheduled an appointment today to see a coworker (name withheld) because her primary is not there today. As she coughs it pounds in her head. That is getting worse. All started 02Dec2022, except cough, it started last night. Headache not constant. Mostly when she coughs. Fever, chills are constant. Has them in mid morning and late evening. Preceded by chills and Body Ache. Headache it felt like it was the same, but now it is worsening because her head pounds when she coughs. Body aches when wakes up in the morning, wakes up the same and is not changing, and so is the loss of appetite. It is the same not worsening or better. If she had an adult to stay with her daughter, she would have gone to the ER last night. Loss of appetite, not complaining because she has ben wanting to lose weight but not wanting to do it that way. She wanted to fortify herself because she was seeing a lot of patients with viral symptoms. Had a coworker that had it last month. She only had soreness in arm and nothing this month. She did have a few days of soreness in arm and then it is better. She did not wish to complete report for her and unable to confirm which vaccine she received. Previous Pfizer COVID vaccine products: 1st dose 14Jan2021 got in (state name withheld), Lot EH9999, expiration 14Jan2021. Says 16:00 but she got in the morning, thinks that is the time it expired. Needed to get glasses to see it and confirmed she needed prescription glasses prior to getting the Pfizer COVID vaccines. Injected in Unknown arm. She thinks it is the right arm and thinks she got all of them in the right arm. 2nd dose 03Feb2021, Lot EL9262, expiration is 03Feb2021 at 14:00 but she got it at 10:25, so it was not expired. Injected in right arm. Of all 4 vaccines, besides this one that she received on 01Dec2022, this is only other one she had reaction to. She has a picture of the reaction she got on this 2nd one. This 2nd dose is what gave her red wheel on arm. Itchy and tender and lingered for a few days and went away. The first and third one had zero symptoms. Pfizer COVID vaccine Booster for last year was 3rd dose: 01Dec2021, Lot FJ1620, expiration unknown, injected in right arm. She takes no other medications except Vit D, C, Zinc and does not take them regularly. No prescription medications.She does not have any medical conditions. She did COVID test and she does not have result, but they showed it to her on Tuesday and it was negative. Confirmed it was this past Tuesday on 13Dec2022. Tylenol and Advil have been her friend since then. She takes it everywhere she goes. Feels insecure without it.  Pfizer/BioNTech COVID-19 Vaccine Follow-up Questionnaire. Time: 18:00. 4.Vaccination Facility Type: Pharmacy. Vaccine Administered at Military Facility? No. 5. Prior Vaccinations (within 4 weeks): none. She had flu vaccine, but that was in Sep2022, which was more than 4 weeks prior to this. 8. Family Medical History Relevant to Adverse Events (AEs): none. 11. Adverse Events: No medical treatment other than Tylenol and Advil. The caller refers she got the gray cap Pfizer BioNTech COVID-19 bivalent on 01Dec2022 and on 02Dec2022 she started with headache, cough, fever, chills, loss of appetite and body aches. After two weeks of having this, on 13Dec2022 she had a COVID-19 test and was negative. I cannot work. I cannot think of my family. It is so bothersome. When I cough there is a pound in my head. It makes my headache worse. What can I do?.I am the breadwinner for my family and I am not able to work. Is there any program.; Sender's Comments: Based on the available information in the case, the causal association between the events headache, cough, chills, pyrexia, decreased appetite, pain, illness, tremor, weight decreased and the 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.