Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Presyncope, Rash, Sensory disturbance, Tinnitus, Vaginal haemorrhage
Clinical narrative: really dizzy; nausea; rushes of chills; balance problems; Rash on arm; hearing problems; couldn't stand in the shower, it knocked out her vestibular system; couldn't stand in the shower, it knocked out her vestibular system; numbness and tingling; numbness and tingling; problems with hot and cold; vaccine messed up the patient's sensory/Every breath out was chills, it was a sensory thing; vaccine messed up the patient's sensory- her ears were messing up and so were her eyes; vaccine messed up the patient's sensory- her ears were messing up and so were her eyes; neck was so stiff; Flu symptoms; vaginal bleeding; arms were beat red; left arm from her first vaccine still swollen; ringing in the right ear; felt like she was going to black out; This is a spontaneous report from a contactable nurse (patient). This 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm on 20Mar2021 at patient age of 56-year-old (Lot number ER2613) as single dose for COVID-19 immunisation. The patient's medical history included menopause for 2 years, asthma, migraine. The patient's concomitant medications included normal inhalers and steroids for migraine. The patient previously received second dose of hep B vaccine 20 years ago for immunization and experienced rash and short of breath. The patient experienced nausea from 22Mar2021, really dizzy from 22Mar2021, balance problems from 22Mar2021, flu symptoms from an unspecified date in 2021, hearing problems from 22Mar2021, Chills from 22Mar2021, vaginal bleeding from an unspecified date in 2021, rash on the arm from 22Mar2021, Ringing in the right ear from an unspecified date in 2021. The patient's first side effect was Sunday night, she was dizzy. The patient later clarified and confirmed that the dizziness started on 22Mar2020, she was on the treadmill and was really dizzy. Right after that, it was between day 3 and 7 that the patient couldn't stand in the shower, she had nausea, dizziness, and rushes of chills. Because of the chills, the patient had to replace the heating pad and electric blanket. The patient stated when listen to music and get chills. The patient could not stand up in the shower and the nausea was unreal, it knocked out her vestibular system and felt like she was going to black out. The patient also had problems with hot and cold- its her autonomic system. After the first dose the nausea improved but wasn't 100% back to normal. The patient could drive to the hospital but while she was doing so she felt like she was in a submarine.  The patient's symptoms improved after the first dose but the second dose amplified everything. The patient was not able to ride the exercise bike and felt like she was going to black out when she looked around. The vaccine messed up the patient's sensory- her ears were messing up and so were her eyes. The patient can't take anything in front of her face. The patient couldn't tolerate the water on her legs in the shower or tilt her head back because her neck was so stiff. The patient has only washed her hair 4 times since she received the vaccines because of this.  The patient's neck felt colder whenever the nurse pulled back the plunger and the nurse put the vaccine in the patient higher than other people do. The first 3 weeks the patient thought she was going to stop breathing. Every breath out was chills, it was a sensory thing. The chills run down her arms. The numbness and tingling can be increased by sound. If a plane flew over it was almost like she would black out. The patient didn't know what's causing it. The patient has gone to the emergency room several times. They keep telling the patient to take dramamine and give it another week, take dramamine and give it another week, take dramamine and give it another week. The numbness and tingling started in the patient's feet and came up her legs. The patient's arms were sore with a rash, and her legs felt like a rubber band. The patient had to drag her legs behind her to walk because she couldn't walk.  The patient also stated her arms were beat red and the left arm from her first vaccine still swollen. The events required emergency room visit and physician office visit. The patient received treatment for dizziness, nausea, chills. The reporter assessed the events related to the Pfizer COVID vaccine. The outcome of the events nausea, really dizzy, was resolving. The outcome of other events was unknown.; Sender's Comments: The event of Presyncope is assessed as possibly related to the suspect drug BNT162B2 based on temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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.