Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Therapeutic response unexpected, Visual impairment, X-ray
Clinical narrative: Swelling went down immediately by 80% in her foot; severely affected on some hearing and vision changes/ Hearing was off and vision was changing in front of her face; severely affected on some hearing and vision changes/ Hearing was off and vision was changing in front of her face; head hurts/ headache; stiff neck/neck is really stiff; feel tired; Feel tired was reported as worsened; she had an allergic reaction to the Covid-19 shot; hot and cold feeling; voice is starting to change; weak; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: TW0179) via an unspecified route of administration in left arm on 22May2021 at 15:00 (at age of 69-years-old) as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure (diagnosed 3-4 years ago) and ongoing rheumatoid arthritis (diagnosed 3 years ago). Patient was pregnant with twins with 1 ovary, 1 tube, on the pill and on her cycle. Patient doesn't take medication for her high blood pressure because there are so many side effects and when she goes to her physician's office, after she walks up 2-3 flights of stairs and walk to the office her blood pressure was up. At anytime patient enters the doctor's office, just gets hyper and her blood pressure goes up but other times it's been fine. When she was diagnosed with high blood pressure 3-4 years ago, she was on valsartan (DIOVAN). As it was the regular brand so it was expensive, but was the only medication that worked for her and she was so stressed at the time and her job had her so stressed out. Now that that's over, her blood pressure went down and weaned herself off of the valsartan (DIOVAN). She definitely doesn't take that medication for rheumatoid arthritis because there are so many side effects and it affects her and just tries to deal with it and exercise and eat properly. She has been on different kinds of medication for her rheumatoid arthritis and none work and the medication would make her sick, just different side effects, like her stomach hurting all the time, dizzy, all this. She took ibuprofen, 800 mg for rheumatoid arthritis and takes as needed. Concomitant medication was not reported. Patient did not receive other vaccine in four weeks of vaccination. No adverse events following prior vaccinations. On 22May2021, patient had severely affected on some hearing and vision changes/ hearing was off and vision was changing in front of her face, at 15:00, the swelling on the left foot went down drastically (fractured left foot) that the vaccine pulled swelling down about 75-80% in her foot. In May2021, patient had stiff neck/neck was really stiff wherein wearing a neck brace just to sleep and had head hurts/ headache that goes from back of neck up my head, feel tired and weak and had an allergic reaction. Feel tired was reported as worsened. On an unspecified date in 2021, patient voice was starting to change, and a hot and cold feeling and missed appointment for second dose of COVID-19 Vaccine. Patient has a fractured foot, which she didn't know that it was fractured until she went to the doctor, so her foot was swollen when she went to get vaccine. As soon as she took the shot, the swelling went down immediately by 80% in her foot. She reported that she thought there must be some serious steroids in the shot for her foot to go down like that. Patient couldn't see hardly and took a shower and went to bed, and when she woke up, it was the same way. It has not changed, her vision has changed and her hearing is off. Hearing was off and vision was changing in front of her face and it was like she was in a swimming pool and it feels like she was in the water and there's water in her ears, or like in a plane like where you have to chew gum or swallow to pop your ears. No matter what she does, her ears was not clear. She began feeling tired about 3-4 days later after receiving vaccine. She was feeling a little tired here when it originally began, but yesterday 14Jun2021 and today 15Jun2021 and the last couple of days, were very bad, it was like she was getting more tired. She feels like she needs to lay down to rest and that she had to lie down yesterday for over an hour. Patient was thinking that she may be more tired because she didn't took the second vaccine and maybe she needs to take it to get her energy. Patient stated that if the first dose of the COVID-19 vaccine has done her this way, she's heard a lot of people say that they have serious side effects to the second dose of vaccine and was hoping that the second one was not going to do any harm but wondering if should take the second dose of the vaccine. She inquired if should wait a little longer before taking the second dose of vaccine or if she should take it now. As reported that she doesn't need to take the second dose of vaccine if she was having these side effects, especially with her hearing and vision. Caller reported that she could expect diarrhea or headache or muscle pain, but it was serious for her ears, vision, and hearing to change so drastically. Swelling went down immediately by 80% in her foot but was still swollen about 20% and her doctor couldn't believe that the swelling in her foot had decreased so much and sent her for an MRI and that they knew her foot was fractured from X-ray. Hearing was off and vision was changing in front of her face and there has been no change in her vision or hearing since it changed. Her vision and hearing are still the same and she can't get it to come back. It was like water in her hear and she can't get the water sound out. Patient can't see at night, especially when trying to drive and doesn't wear glasses or anything, just had a contact that she could wear if needed. She was prescribed glasses as well, and she put on the glasses but her vision was still blurred. Her vision has changed drastically. Headache started around the same time that the vision and hearing changes occurred. Caller reported that the reason that she says that the headache might not be related to the COVID-19 vaccine was because she has a neck injury and her rheumatologist told that it could be arthritis in her neck now. Patient slept in a neck brace to keep her neck in place and keep it from hurting. The stiffness in her neck started back after she received vaccine. Caller reported that she has had stiffness in her neck before but seems different this time and thinks had a neck problem but for it to stay centralized in the area on the left side coming up to her head, that's what was bothering her. On unspecified date, blood work and MRI was performed and result were unknown and X-ray results foot was fractured. Reporter seriousness for swelling went down immediately by 80% in her foot, hearing was off and vision was changing in front of her face, headache that goes from back of neck up my head, neck was really stiff, feel tired and missed appointment for second dose of covid-19 vaccine was unspecified. Adverse events do not require a visit to emergency room or physician office. Outcome for events swelling went down immediately by 80% in her foot, severely affected on some hearing and vision changes/ Hearing was off and vision was changing in front of her face, head hurts/ headache, stiff neck/neck is really stiff, feel tired, Feel tired was reported as worsened. was not resolved and for other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.