Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Loss of consciousness, Malaise, Migraine, Pyrexia
Clinical narrative: Some visual hallucination during this time and it was very strange and horrible; wasn't feeling good; She was sleeping all the time; Migraines has come back; Migraines has come back; chills; High Fever; couldn't see, that was the strange thing because everything was like shadows black and white very dark; Urinary tract infection; Fibromyalgia; blackout; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: 048C21A), via an unspecified route of administration on 21Jul2021 (received at the age of 74-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The vaccine was administered in the doctor's office. Medical history included rheumatoid arthritis from 2019 and ongoing (started 2 years ago), Post-polio (Post-polio when she was 6-years-old and she is suffering from Polio effects), anemia from an unknown date and ongoing (she goes once a year for Iron infusion), lung issues, covid-19 from Mar2021 to an unknown date (Covid infection), Spinal injury (had accident spinal injuries and pain between her shoulders from the compressed fracture of T-7 vertebrate), accident, hypertension and migraines off and on (off and on for 3 years). Concomitant medication(s) included methotrexate (NEOTREXATE) taken for rheumatoid arthritis, start and stop date were not reported; prednisone (PREDNISONE) taken for rheumatoid arthritis, start and stop date were not reported; folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported; baclofen (BACLOFEN) taken for an unspecified indication, start and stop date were not reported; propranolol (PROPRANOLOL) taken for hypertension, start and stop date were not reported; diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported; famotidine (TOPCID) taken for an unspecified indication, start and stop date were not reported; omeprazole (PROTONIX [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; paracetamol (ACETAMINOPHEN) taken for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for an unspecified indication, start and stop date were not reported; aciclovir (ZOVIRAX [ACICLOVIR]) taken for an unspecified indication, start and stop date were not reported, and iron infusion. The patient previously received flu shot and had terrible side effects from it (unspecified). The patient stated that there were a couple of things; she has trouble remembering is one of her problems. She just had the first vaccination and had some pretty awful side effects, but her Doctor encouraged her to go ahead and get the second (dose) vaccination. The doctor had her wait a while because she was just physically in no shape to have the second inoculation when she should. So, when she did go in to get her inoculation (vaccination), she went to the (Pharmacy), which was not where she got her first inoculation. Her first one was at the Doctor's office but she was not in town here and she couldn't find anybody to drive her and so she went ahead and scheduled for it at (Pharmacy) where she gets her prescription. When she went in to get her second dose shot, the Pharmacist wanted to know why she have waited so long in between first dose and second dose vaccination. She was asking her some questions and her told her about the side effects. The pharmacist asked her if the Doctor recommended her to get a second shot. The pharmacist told her that (Pharmacy) would not give her a second dose shot with those side effects without a Doctor's prescription (recommendation), a written prescription from her Doctor. She wasn't feeling good when she went to get her second dose shot, so she was kind of afraid and it has been 2 weeks since that day; she have slept most of those 2 weeks and she can't stop sleeping. She had Covid infection (history) in March2021 and when she had her first dose vaccination shot, it was like having Covid infection all over again but much worse. All the things that happened to her when she had Covid, in first dose were much worse. Apart from it, her memory was just a mess. She was sleeping all the time and her migraines has come back. She had Migraines off and on for 3 years and she was finally was over it, but her migraines have come back. The patient also stated she has Rheumatoid Arthritis which started 2 years ago (2019), and she takes medication Neotrexate 2.5 mg (one tablet in a week). She stated that her Rheumatologist was very considerate. He took her twice off Neotrexate twice before she got her Covid Vaccine because he was afraid that her resistance would be so low, and she did get Covid first dose. Despite staying at home all the time, she had to go to the Hospital for Endoscopy. Six days after she got the Covid Vaccine, on 27Jul2021, she had Fibromyalgia. She had Post-polio when she was 6-years-old, and she is suffering from Polio effects (history). She also had anemia terribly (history) and she goes once a year for Iron infusion. She wasn't surprised when she had side effects from the Covid shot because she had terrible side effects from a Flu shot. She had reached when she had called to cancel, that's the only way she could cancel her second vaccination (through call). She stated, "I guess I did it, I did it through text or maybe Email. I am not sure, but it was the same system where I had registered, so I went back in and cancelled my second dose vaccination but had to reschedule, my rescheduled date for second dose is for today and I haven't gotten any written permission from my Doctor yet. I am really nervous about not getting my second vaccination but at the same time, physically I don't feel up to it." The patient stated that she lives alone, and it was very frightening. The first time, she was blackout without any warning to this happening. In evening that she had her first vaccination (21Jul2021), she was blackout for 38 hours and fortunately she was in her bedroom. She had been out in her front porch and she was feeding her cats. She came in and she can't remember why she came in the house. She came in the house for something, and she thought, she just got her laundry folded on the bed. She better get that off the bed and that was it. She just passed out for one and half hours in her bed. She just came in couple of hours before she thinks. She had chills and she just collapsed. She couldn't figure out where she was because it was so lousy, and she was on the laundry and she just had something over her and then she was blackout again. The next time, she was running a high fever and she couldn't see, that was the strange thing because everything was like shadows black and white and very dark. She just listened, it was nighttime, but that went on for a long time. She would come to and everything would be dark before she could figure out what was going on. She would be gone again. When she finally came to, all the lights were on, so she doesn't understand the dark. One of her cats has never come into the house. She was under her bed crying because her cat is very attached to her, so she thought she was hallucinating, she had some visual hallucination during this time, and it was very strange and horrible. Anyways, she just doesn't feel that now and she is up to going through this again. She wants to get back to her treatment (concomitant medications); she's wondering what is going to happen. When probed for any laboratory test, consumer stated, "I had a bunch of lab tests, but we had to reschedule everything. My iron infusion was in May2021 and I did have lab some radiology." When probed for laboratory test results, consumer stated, "No, because I don't remember." When probed for any treatment for the events, consumer stated, "I called the Doctor he didn't. She called me back when I got again. I called the day when I came to, when I called her few days later because I wasn't getting better, and I had to go to Emergency room. They had whole bunch of radio cardiologist test and they all came back, and it was all pretty good, and they sent me home. They discovered that I had urinary tract infection, so they gave me antibiotic for urinary tract infection." Outcome of the events was unknown. All the events required a visit to the emergency room.   Follow-up attempts are completed. No further information is expected.