Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Dizziness, Drug ineffective, Insomnia
Clinical narrative: Covid-19; Covid-19; After receiving arm was hit; felt nautious in the days; after i became unable to sleep for days in a row; but unable to keep my eyes open; i nod out fall get dizzy but i can not sleep for more than 15-30; Back Pain; can't work; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2021 at 07:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies. The patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. Other medications in two weeks reported as no. The following information was reported: LIMB INJURY (disability) with onset 26Sep2021, outcome "not recovered", described as "After receiving arm was hit"; BACK PAIN (disability) with onset 26Sep2021, outcome "not recovered"; INSOMNIA (disability) with onset 26Sep2021, outcome "not recovered", described as "after i became unable to sleep for days in a row"; SOMNOLENCE (disability) with onset 26Sep2021, outcome "not recovered", described as "but unable to keep my eyes open"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability) with onset 26Sep2021, outcome "not recovered", described as "can't work"; NAUSEA (disability) with onset 26Sep2021, outcome "not recovered", described as "felt nautious in the days"; DIZZINESS (disability) with onset 26Sep2021, outcome "not recovered", described as "i nod out fall get dizzy but i can not sleep for more than 15-30"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "Covid-19". The events "after receiving arm was hit", "felt nautious in the days", "after i became unable to sleep for days in a row", "but unable to keep my eyes open", "i nod out fall get dizzy but i can not sleep for more than 15-30", "back pain" and "can't work" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2022) Positive. Therapeutic measures were taken as a result of limb injury, nausea, insomnia, somnolence, dizziness, back pain, loss of personal independence in daily activities. Clinical course: After receiving arm was hit felt nautious in the days after she became unable to sleep for days in a row but unable to keep her eyes open, she nod out fall get dizzy but she could not sleep for more than 15-30 T a time trouble with back pain. Stated that, she never had, if she walked to much she couldn't catch her breath, the worst was the sleeping. Stated that, she got two three days with small 15 min naps but she kidd out and fall asleep driving, she couldn't work due to this. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage]. No covid prior vaccination. Covid tested post vaccination was reported as yes, Covid test type post vaccination: Nasal Swab on 04Jan2022, resulted as Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, the causal relationship between the reported 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