Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Insomnia, Malaise, Muscle swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318, Expiration Date: 29Jan2021) via intramuscular on 29 Jan 2021 at 18:29 (at the age of 75 years old) as 1st dose, single for COVID-19 immunization. Medical history included, fibromyalgia, rheumatoid arthritis and hypothyroidism. Concomitant medication included levothyroxine taken for hypothyroidism since 20 years and trazodone since 2 years. The patient previously took acetaminophen and experienced drug ineffective, tylenol and experienced drug ineffective, aleve and experienced drug ineffective, influenza vaccine for influenza and experienced pyrexia. On 29Jan2021 at 1.10 pm the patient experienced injection site pain started, at night it got worse, the patient experienced couldn't breath, head was stuffy and pounding, like sinus clog all over my head, muscle pain, on my heart chest, on that side was much painful to breath/chest where her heart is it was painful, chills, nausea, felt unwell , aching with muscle pain and bones, face getting swelling/face was swollen, rash/had a rash, started on her face, it was a little swollen and her neck, still has neck on her face and some one her eyebrows and her eye, nerves and muscles are so tight, muscle was so swollen, dizzy, no energy, nauseated, misery, tiredness, headache and body aches. It was reported that the patient waited 15 minutes after the vaccination, she went home, in the evening injection site pain started, at night it got worse. she got her, there were times she couldn't breath, then she sat up, it was scary. her head was stuffy and pounding, like sinus clog all over her head, muscle pain when she got up, on her heart chest, on that side was much painful to breath. The worst thing happened in the morning she started having really bad chills, She took acetaminophen in the morning, but it didn't do nothing. That day she got very big chills, started nausea, felt unwell and couldn't get up and didn't want to get up. She is an active person and walk 5 miles per day. Her body started aching, so much aching with muscle pain and bones, like someone got a hammer on her. She wanted someone to hammer her, she didn't want to live. She have had allergy shots and was never like that. She thought maybe she had the virus and didn't know what was going on. She texted her doctor and he answered. The patient took Tylenol, a little better, but pain was not gone. Wednesday when her face getting swelling, she was getting up and walking in her apartment and felt dizzy. All her upper body was so much sore. Aleve usually makes her better, She texted her doctor again and he didn't answer, so she took 2 Aleves, it helped muscle pain, but still had the chills and nausea. She is 75 percent well today. She got a rash Wednesday night, it was better but she was having feeling. She didn't want to keep living, but she now don't have those feelings anymore. Her rash was on neck and throat right now, She don't care because she is getting better. She have been on all the websites and CDC. She can't find any information. Her doctor told her that he had a patient that had a week of symptoms. She used did get the reaction from a flu shot years ago, but she got it later, it wasn't anything, it used to go away after a day or so, a fever. The patient had typhoid and she would get fever and her arm swollen. She explains that her sister sister got the (Manufacturer Name), she got a fever one day and now she is fine. Patient said she was not blaming anybody. She knew everybody is different, it is her body. The patient asked if she should get the 2nd dose or not. The patient reports she have been holding the call for 45 minutes. she can't find any information and her doctor doesn't know what to do. She just went through all websites and the problem is she had this vaccine, the Pfizer. she did get the first dose on last Friday. Around 1:30 she was out, 15 minutes they let her sit, nothing happened. she don't react to anything right away, she react later, couple of days or something, this is her body. They let her sit nothing happened. she took the rise, her friend took her. She kept for safe side if something happened. She still have symptoms, so they gave her the guidelines and it's so confusing when to go to the doctor or not. She had injection site pain, that's very common so it no tiredness, headache, head was not a headache, she still have headache. She reports it was 'confusing' like she don't know what to do, her nerves and muscles are so tight and have a headache on the side. And muscle pain, her shoulder in the back and also where her heart is, on that chest muscle was so swollen that she woke up couple of times at that Friday night, few things that woke her up. So, it's sometimes like can't breathe, she had to get up to breath couple of times and that was like oh her god what's happening now. After that in the morning what just happened, so anyways get down and walked a little bit and then she just want to, she didn't know what to do. She informed that the nurse told her, told her that you she take the Acetaminophen. So, then in the morning she took acetaminophen but it didn't make me any difference. she started having so much chills, so much muscle ache that no matter how much blanket, how much she took, how much heater turn on, she still having chills. And she know chills are the sign of infection her body is fighting whatever is inside her, whatever the dose is. And then she didn't have fever but nausea a big time, her mouth taste so bitter and her unwell, she is feeling so not well. So, she didn't know what to do, so she just anything. She like tea or coffee (incomplete sentence). She got it a little, she was better first day. And then she had little bit swelling on her face on Wednesday, rash on her face and swelling, it didn't happened first and then on her neck, rash. Those things she felt on Wednesday she feel dizzy also. She just wanted to make sure she didn't know what to do, when to go to the hospital and what not. She askes if she can take the second dose or she can still take monoclonal antibody therapy. The patient reported that she nauseated still and her head still hurts. she still have no energy. She didn't know that, she was ready for couple of days to get a fever and get it over with, no problem. But this was very bad experience just like she had the virus. Patient did not give information about acetaminophen. The nurse told her to take Tylenol and acetaminophen, and the patient stated Tylenol helped some. States her chest where her heart is it was painful and she could not breathe, and she was thinking she should go to the emergency room, Tylenol made it a little better. On Wednesday it was worse. She informed she walks 5 miles, very healthy. Even yesterday, last night, she had a rash, started on her face, it was a little swollen and her neck, still has neck on her face and some one her eyebrows and her eyes, it is better than yesterday. She wanted to just crawl out of her body. She used to get little reaction when get flu vaccine. She wanted to go to the hospital but was afraid they would tell her she is still breathing, she wanted to know if she should get the second dose. Her doctor stated that maybe she should get monoclonal antibody treatment. Stats that in (Country Name) they do not have beds, they cannot afford oxygen and they don't have hospital beds, they have been doing it along time, they don't admit the COVID-19 patients they give them this therapy outpatient and then let them go home. They have been doing it for a while, about 2 months ago. Patient declined to provide any specific details for a report, she thought she was being transferred to medical information to begin with. She wanted to just transfer her, sometimes they do not give you an option when you call in. She said she would rather die than feel that way again, that her children have jobs and lives and she is happy about that. Upon follow-up on 10Mar2021, date of vaccination, lot number and route of administration was updated. Events were assessed as non-serious. She received Tylenol, Ibuprofen, Aleve as treatment. Outcome of the events were recovered on 19Feb2021. Follow-up attempts are completed. No further information is expected.