Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nervous system disorder, Pyrexia, Visual impairment
Clinical narrative: visual and neurological issues; She says she got her phone and it affected her brain; her fever went down; She gives her height and says that she shrunk; hoarse was reported as worsened; hoarse; slept a lot; 12 to 16 hours for the next 5 days; trouble walking; trouble seeing; This is a spontaneous report from a contactable other nurse (patient). This nurse reported 2 reports for same patient, this is first of 2 reports. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 25Feb2021 11:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing asthma, she says she has been having respiratory problems and asthma since she was a teen; covid-19 from 06Feb2020 to 18Feb2021, She says she didn't see her doctor until the day she got better. She says she realized she was in big trouble and need help. She says she got her phone and it affected her brain. She says she she 5 sons and she flipped around her phone having trouble. She says he has had the same phone for 4 years. She says she was fine that day, 18FEB2021, that she had half of the symptoms, and her fever went down. She says the headache lasted a while; allergies; No thyroid gland, clots; thyroid cancer; termors that started 7 years ago in one hand. She says she has no thyroid gland. She says she has been taking this since her surgery; she was around 33 years old, and she is 66 now, so for 33 years. She says she had clots. History: She says she takes a lot of medications, a lot of neurological medications. She says the only other pertinent thing is she does have tremors that started 7 years ago in the one hand. She says just before she got the COVID virus, a week before, tremors started in the other hand and progressed rapidly. It is remarked that she thinks she was infected when this started. She says the other one took 7 years to be once a day while this one progressed to be daily. She says she does not take anything for that, she is just trying to increase her activity levels. She says when she was 30 or 40 she was very active. She says the doctors think there is something wrong with her immune system. She says they are trying her on diff medications for asthma; they changed it, added more. She says Advair work beautifully and she doesn't use a breakthrough inhaler. She says ever since COVID in 2020, the first week of FEB2020 she thought it was the flu. She says she didn't get any medical help, she was in severe shape, and her headache was severe. She says she crawled to the bathroom once a day, she had a high fever and it felt like a snake effect of a cobra all over, squeezing.   She says her pulmonologist gave her Spiriva and that has opened her up, once a day. Caller had gotten to the point she couldn't take 5 or 6 steps and couldn't breath. She gained a ton of weight cause she couldn't move related to this breathing issue. She thought she wouldn't recover, he gave samples once a month. She says she saw him a week ago, 10 days ago maybe. She says she had shortness of breath and couldn't walk. She clarifies she is talking about when she had COVID last year, not this current shot report. She says she didn't consider these current side effects a problem, she expected some side effects and they went way. She says the shortness of breath walking problem was due to shortness of breath; that was what happened with COVID. She says her hoarseness is related to spring allergies and is due to the climate and it is usually from 10APR to 16JUN. She says she gets a sinus drip and congestion and that she is on 5 different medications for that. She says she has more trouble with inhouse allergies. She says she gets trouble as soon as the trees pop. She has had hoarseness for about a year and the allergies have really started around 10Mar2021 for this year. Concomitant medication included ongoing levothyroxine sodium (SYNTHROID) taken for thyroid cancer. She says something new was 8 weeks out she got the flu shot. She says she has a lethal allergy to egg white so she has never had a flu shot her entire life. She says she asked her doctor why they didn't get the one without egg whites. She says they made one without egg white in the 1990's. She says 08DEC2020 was her first flu shot. She says everyone wants her to take more shots but she won't take any more. She says COVID and the flu shot are enough for one year. She says if they have the COVID booster then she will take that one but not any other. She says no but she was told don't ever have anything with egg white in it so she never had the flu shot, she refused. The patient took first dose of BNT162B2 on 04Feb2021 for COVID-19 immunisation and experienced headache. The patient experienced trouble walking (Disabling) on 25Feb2021 19:00 (about 7:00pm in the evening) with outcome of recovered on 25Feb2021, trouble seeing (Disabling) on 25Feb2021 19:00 (about 7:00pm in the evening) with outcome of recovered on 25Feb2021, hoarse was reported as worsened (medically significant) on Mar2021 with outcome of not recovered, hoarse (medically significant) on Mar2021 with outcome of not recovered, slept a lot; 12 to 16 hours for the next 5 days on 25Feb2021 22:00 (10:00pm at night) with outcome of recovered on 2Mar2021. The caller is calling about the COVID 19 vaccine. She says she had side effects but she would consider them mild. She says the shot was wonderful. She says she has put off reporting this. Caller remarks she has shrunk, when providing her height. Caller apologizing when clearing her throat, says sorry she is so hoarse today. She says the second dose they came and went away. She says the second shot was at 11:00 am. She says the second shot was on 25FEB2021. She says she had a lot of water to drink then 7 hours after the second shot, about 7:00pm in the evening, she had 45 minutes of visual and neurological issues. She says she had trouble walking, she was stumbling with her feet, she had trouble with eyesight, different sections of her vision was together. She says this was like when she had 5 children. She says her pregnancy during the first 3 months she had neurological visual experiences of shadows put together and at the end of the pregnancy, 2 months after delivery, it would go away. She says she is in an apartment and she sat down then it was 45 minutes total for both occurrences at the same time. She also reports that she slept a lot; 12 to 16 hours for the next 5 days. She says on the 6th day she was fine, no symptoms and no sleepiness. She says it occurred the evening at 10:00pm at night, then it went up through the 5th day afterwards. When asked seriousness of the sleeping event she says none of the above. She says she she lives in a senior housing area, they all got it at the same time, that there was only one person who declines. She says almost everyone had sleepiness for at least 3 days afterwards. She says she is still battling the COVID after effects, it was disrupting her breathing. She says she was glad she got the shot, she is glad she was able to do it. She says her second dose seemed to be around 11:00am. For the second dose lot number she reads GL92 then AA or 00. She does not see an expiration date or NDC number for the first or second dose. She says her second dose was in her left arm up high near the shoulder, upper arm high. She says she didn't feel either of them. She says that she was put on BREZTRI Expiration date, lot number, and NDC number not provided. She says her doctors thought she had COPD but she didn't; it doesn't work for people over 70. She says the cardiac problem was with a respiratory medication. She says it was Trelegy. She does not have an expiration date, lot number, or NDC number for Trelegy . She says she is not sure where she put the container but she does have it somewhere. She says it affects the QRS. She says when she had COVID she was sneezing and in August her hair fell out. She says she had a fever for 4 days that week then she went away. She says she wondered if she had the long haul COVID. She says the doctor gave her something to make her lungs spring open. She says she is currently hoarse due to spring allergies, not because of the shot. A medication called Breeze didn't work for her. She says that she was put on BREZTRI Expiration date, lot number, and NDC number not provided. She says her doctors thought she had COPD but she didn't; it doesn't work for people over 70. No additional vaccines administered on same date of the Pfizer suspect. All events did not require a visit to Emergency Room or Physician Office. No family medical history relevant to AE. No relevant Tests. The reporter considered events trouble walking, trouble seeing, slept a lot; 12 to 16 hours for the next 5 days were related to covid 19 vaccine, event hoarse was unrelated to covid 19 vaccine. The outcome of other events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information there is not a reasonable possibility that the drug contributed to occurrence of the events, a possible contribution of the drug to the event pyrexia 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.,Linked Report(s) : US-PFIZER INC-2021493623 same patient/drug, different vaccine dose/event.