Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging, Muscular weakness, Ocular discomfort, Pain
Clinical narrative: Couldn''t hardly walk, legs gave out on her; dizzy / Dizziness; tingles in her right hand going down to her right leg, then into her right foot / felt the tingling again in her right hand.; Asthma; Eye pressure /affecting her eyes; Feeling weak / really weak; Head pressure; weird feeling / Didn't feel good the night of the vaccine /feeling really bad / still feels weird in her head; neurological stuff that happened; passed out; Couldn't focus on things; Eyes started hurting; inflammation in her eyes; slowly getting her lungs better; Just had a menstrual cycle one week before the vaccine / Another menstrual cycle and cramps; couldn't do anything; could hardly breathe; Another menstrual cycle and cramps; Just had a menstrual cycle one week before the vaccine / Another menstrual cycle and cramps; blood pressure was dropping into the 50s; Headache / Head was hurting so bad; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. Patient worked, but not in the hospital .The report was not related to a study or programme. A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 around 4:50-5:00PM  (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sleeping problem" (unspecified if ongoing), notes: no issues except for sleeping problems sometimes; "back injury", start date: Dec2020 (unspecified if ongoing), notes: car wreck in Dec2020 and had a back injury that finally healed and she was feeling better; "car wreck", start date: Dec2020, stop date: Dec2020. Family history included: "COPD" (unspecified if ongoing), notes: Mother has COPD.  No additional family history. She stated her whole family did fine with the Pfizer COVID-19 Vaccine. She works with children. She was a healthy person and had no issues except for sleeping problems sometimes. She never experienced the head pressure she had. Concomitant medication included: LUNESTA here and there to sleep for insomnia, and vitamins. Never had had problems. Past drug history included: Rizatriptan for migraines. No prior Vaccinations (within 4 weeks). Patient had not had vaccines since the childhood vaccines. She did fine when with childhood vaccines, did not get the Flu shot. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset Aug2021, outcome "recovering", described as "passed out"; BLOOD PRESSURE DECREASED (medically significant) with onset 2021, outcome "not recovered", described as "blood pressure was dropping into the 50s"; HEAD DISCOMFORT (non-serious) began that night of 19Aug2021, outcome "recovering", described as "Head pressure"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache / Head was hurting so bad"; EYE DISORDER (non-serious) with onset 19Aug2021, outcome "recovered" (2021), described as "Eye pressure /affecting her eyes"; ASTHENIA (non-serious) with onset 19Aug2021, outcome "not recovered", described as "Feeling weak / really weak"; GAIT DISTURBANCE (non-serious) with onset 22Aug2021, outcome "recovering", described as "Couldn''t hardly walk, legs gave out on her"; ASTHMA (non-serious) with onset 20Aug2021(also reported as 20Aug2021), outcome "not recovered", described as "Asthma"; PARAESTHESIA (non-serious) with onset 21Aug2021, outcome "not recovered", described as "tingles in her right hand going down to her right leg, then into her right foot / felt the tingling again in her right hand."; DYSMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Another menstrual cycle and cramps"; MENSTRUATION IRREGULAR (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "Just had a menstrual cycle one week before the vaccine / Another menstrual cycle and cramps"; FEELING ABNORMAL (non-serious) with onset 19Aug2021, outcome "not recovered", described as "weird feeling / Didn't feel good the night of the vaccine /feeling really bad / still feels weird in her head"; DIZZINESS (non-serious) with onset 22Aug2021, outcome "not recovered", described as "dizzy / Dizziness"; DISTURBANCE IN ATTENTION (non-serious) with onset Aug2021, outcome "unknown", described as "Couldn't focus on things"; DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "could hardly breathe"; EYE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "Eyes started hurting"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "migraines"; IMPAIRED WORK ABILITY (non-serious) with onset 2021, outcome "not recovered", described as "couldn't do anything"; EYE INFLAMMATION (non-serious) with onset Aug2021, outcome "unknown", described as "inflammation in her eyes"; LUNG DISORDER (non-serious) with onset Aug2021, outcome "recovering", described as "slowly getting her lungs better"; NERVOUS SYSTEM DISORDER (non-serious) with onset 19Aug2021, outcome "unknown", described as "neurological stuff that happened". The event "passed out" was evaluated at the emergency room visit. The events "blood pressure was dropping into the 50s", "headache / head was hurting so bad", "eyes started hurting" were evaluated at the physician office visit. The events "head pressure", "eye pressure /affecting her eyes" and "inflammation in her eyes" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) dropping into the 50s; (2021) dropping; (2021) dropping to 50/48; (02Dec2021) upper number was in the eighties, notes: blood pressure was still kind of low; coagulation time: (2021) unknown results; magnetic resonance imaging: (2021) unknown results, notes: MRI next Wednesday (as of 02Dec2021). Patient did MRI in the beginning because head pressure had been so bad; oxygen saturation: (2021) failed; tilt table test: (2021) failed, notes: at the hospital. Therapeutic measures were taken as a result of blood pressure decreased, head discomfort, eye disorder, eye pain, migraine, eye inflammation, nervous system disorder. Patient reported never got the second dose as of 02Dec2021.  Clinical course: Her spirit told her not to get it. She didn't have a good feeling about the COVID-19 vaccine. She couldn't do anything and it started affecting her eyes. It started in the head and went to the eyes for 80 days straight. Initially thought it was the regular stuff. The next day, 20Aug2021, it was worse. Had her spiritual leader and his wife pray over her and it eased up. After 80 days, she couldn't do much. It started easing up some. Patient was still having weird feeling in her head and a headache. Her legs gave out on her on the third day. She started feeling weak. Then started getting tingles in her right hand going down to her right leg, then into her right foot. Then she started getting really dizzy. She thought that was because her blood pressure was dropping. Patient experienced eye pressure about a week later after the vaccine. Couldn't focus on things. Head was hurting so bad. Couldn't look at phone or TV. Eyes started hurting. Went to eye doctor and was told she had inflammation in her eyes, and was given steroids. Couldn't hardly walk, legs gave out on her which began 3rd day after vaccine. This went on for four day and then she passed out. Ended up in the ER. It got better. She didn't feel good the night of the vaccine, but was resting. She was still working on that (feeling weak). She had asthma because she could hardly breathe. She failed the oxygen test she took. She started her walks back and was slowly getting her lungs better, and stated it's ongoing. Tingling in right hand, right leg, right foot began about the third day after the vaccine. The second day after the vaccine she started feeling really bad. The third day, everything started happening. She had it at times. It's weird. Just kind of went away. She had to have blood clot tests. About 1.5 weeks ago (as of 02Dec2021) she felt the tingling again in her right hand. She just had a menstrual cycle one week before the vaccine. Then after the vaccine, she got bad cramps and stated another menstrual cycle. Everything still feels weird in her head. Felt dizzy the other night. Her eyes feel weird at times. She thinks it's neurological stuff that happened. She started feeling dizziness symptoms the 3rd day after the vaccine. Dizziness got really bad probably day 10 after the vaccine. Her blood pressure was dropping. She went to the doctor and could barely get in because she was really weak. She could barely get through the tilt test because she felt like she was going to pass out. Her blood pressure was dropping to 50/48. It was confirmed patient was not diagnosed with Guillain-Barre. Her sinus doctor can't get the vaccine. This doctor thinks the patient had a touch of Guillain-Barre. Treatment included three rounds of Prednisone from (Withheld), trying to get head pressure. (Withheld) thinks the vaccine caused a lot of inflammation. She had taken tons of Toradol (NDC/LOT/EXP was unknown) shots trying to get some relief. Toradol shots work for about 1.5 days. She received them when the pressure was so bad she couldn't stand it. She received one from (Withheld) and four from Urgent Care. She stated Toradol shots cannot be given back to back. (Withheld) tried to put her on blood pressure medicine but patient was seeing a wellness doctor now. Patient was trying to step away from meds. Wellness doctor took patient blood pressure on 02Dec2021 and it was still kind of low. The upper number was in the eighties. She has been dealing with this for three months. She didn't have one symptom with her arm. Patient did MRI in the beginning because head pressure had been so bad. Nothing helped. Patient confirmed she was not admitted to the hospital, was discharged from the ER. Patient had never had any type of breathing problem previously. She went from being able to workout every day, to not being able to run. Then she couldn't walk without taking deep breaths. She couldn't get upset because it would make it harder to breathe. Has taken tons of Toradol shots trying to get some relief.  Neurologist had her on her Rizatriptan for migraines. Was put on that a long time ago. Only takes Rizatriptan (NDC/LOT/EXP is unknown) when she had a headache, but stated this was an every day headache. In regards to the head pressure, stated nothing helped. Confirmed she was still having head pressure as of 02Dec2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101393477 same patient/drug, different vaccine dose/AE