Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: Her blood pressure was also elevated/Blood pressure up to 200/109; She felt a hot and cold reaction but no fever; Dizziness; Shortness of breath; Terrible headache; Ear ache; Sore throat; She was experiencing pain in the left side of her neck; Examined the lymph nodes on the left side of her neck and they were swollen/Swollen lymph node on her throat; lymph node/it was so sore and the pain run down from the left part of her neck to her arm; It was so sore and the pain run down from the left part of her neck to her arm. She also said that under her left arm still feels touchy; Itching now near my the part where I got the vaccine; Burning at injection site on left arm; did not feel well; nauseous; Heart Palpitations; breathing was fast; she was shaky; allergic to the vaccine; Her thyroid hormones got elevated/Thyroid is Wacko; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 17Feb2022, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 70 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergic to mice" (unspecified if ongoing); "allergic to cockroaches" (unspecified if ongoing); "allergic to mites" (unspecified if ongoing); "allergic to molds" (unspecified if ongoing); "allergic to raw sugar" (unspecified if ongoing), notes: allergic to raw sugar; "blood pressure" (unspecified if ongoing); "She doesn't drink nor smoke" (unspecified if ongoing); "She doesn't drink nor smoke" (unspecified if ongoing); "thyroid autoimmune" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL taken for blood pressure management; LEVOTHYROXINE. Vaccination history included: J&j covid19 vaccine (Dose 1), for COVID-19 immunization, reaction(s): "no reaction to J&J shot". The following information was reported: BLOOD PRESSURE INCREASED (medically significant), outcome "recovered", described as "Her blood pressure was also elevated/Blood pressure up to 200/109"; FEELING OF BODY TEMPERATURE CHANGE (non-serious), outcome "unknown", described as "She felt a hot and cold reaction but no fever"; DIZZINESS (non-serious), outcome "recovering", described as "Dizziness"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; HEADACHE (non-serious), outcome "not recovered", described as "Terrible headache"; EAR PAIN (non-serious), outcome "not recovered", described as "Ear ache"; OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "Sore throat"; NECK PAIN (non-serious), outcome "unknown", described as "She was experiencing pain in the left side of her neck"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Examined the lymph nodes on the left side of her neck and they were swollen/Swollen lymph node on her throat"; LYMPH NODE PAIN (non-serious), outcome "unknown", described as "lymph node/it was so sore and the pain run down from the left part of her neck to her arm"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "It was so sore and the pain run down from the left part of her neck to her arm. She also said that under her left arm still feels touchy"; HYPERSENSITIVITY (non-serious) with onset 16Feb2022, outcome "not recovered", described as "allergic to the vaccine"; THYROID HORMONES INCREASED (non-serious) with onset 16Feb2022, outcome "not recovered", described as "Her thyroid hormones got elevated/Thyroid is Wacko"; VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "Itching now near my the part where I got the vaccine"; VACCINATION SITE PAIN (non-serious), outcome "recovering", described as "Burning at injection site on left arm"; MALAISE (non-serious), outcome "recovering", described as "did not feel well"; NAUSEA (non-serious), outcome "recovering", described as "nauseous"; PALPITATIONS (non-serious), outcome "recovering", described as "Heart Palpitations"; RESPIRATORY RATE INCREASED (non-serious), outcome "unknown", described as "breathing was fast"; TREMOR (non-serious), outcome "unknown", described as "she was shaky". The events "her blood pressure was also elevated/blood pressure up to 200/109", "she felt a hot and cold reaction but no fever", "dizziness", "shortness of breath", "terrible headache", "ear ache", "sore throat" were evaluated at the emergency room visit. The event "examined the lymph nodes on the left side of her neck and they were swollen/swollen lymph node on her throat" was evaluated at the physician office visit and emergency room visit. The events "did not feel well", "nauseous" and "heart palpitations" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: antibody test: she has antibodies against the virus; blood pressure measurement: elevated; 200/109; 128/73, notes: Her blood pressure is down; culture throat: negative; investigation: negative; sars-cov-2 test: negative; thyroid hormones test: elevated; thyroxine: 0.005. Therapeutic measures were taken as a result of blood pressure increased, feeling of body temperature change, dizziness, headache, ear pain, oropharyngeal pain, neck pain, lymphadenopathy, malaise, nausea, palpitations. Clinical Course: It was reported that after patient received the vaccine, she felt a hot and cold reaction, but no fever, with dizziness, shortness of breath, terrible headache, earache, and sore throat. Her blood pressure was also elevated and she was experiencing pain in the left side of her neck. She also mentioned that she went to immediate care and the doctor examined the lymph nodes on the left side of her neck and they were swollen. The swollen lymph node on her throat was still there after 2 weeks but has now gone down. She said that the first time it was examined, it was a size of a golf ball but now it has gone down to the size of a nickel. She mentioned that she has no trouble swallowing and has put heat and cold the swelling to help it go down. She also mentioned that it was so sore and the pain run down from the left part of her neck to her arm. She also said that under her left arm still feels touchy.  This was the first time she has experienced this even though she was healthy. She thinks that she may be allergic to the vaccine. It was also mentioned that her thyroid hormones got elevated. She mentioned that her T4 hormone is at 0.005 while the other thyroid hormones have gotten elevated. She also mentioned that she takes levothyroxine. She said that she had an antibody test done to her and the results showed that she has antibodies against the virus. She will be undergoing an ultrasound this weekend. Patient was also itching now near the part where she got the vaccine. She doesn't have hives but was itching. It was also reported that when they put it into her arm, it was burning. It was like it was on fire and she could feel it. Right afterwards, she did not feel well, had heart palpitations, was dizzy and nauseous. The next night, she was in the immediate care clinic and was seen that morning and told doctor she has terrible earache, sore throat, headache, shortness of breath and hot and cold. It felt like it was going through her arm and spread everywhere. They gave her an ice pack to put on it. She did not have any redness or swelling on the injection site. It was puffy (as reported) and hot. She felt like her breathing was fast. She went home and lied down and was quiet and the heart palpitations and breathing got better. With the hold and cold, she would be wringing wet and then ice cold. She was not a sickly woman and was in good health. She was shocked because she was not sick before. She was not nervous with this one and was shocked she had symptoms and has not read about anything, so it calmed down and she took 2 Tylenol and did not have a fever. It took 5-6 hours for the hot and cold to calm down and she was shaky. As long as she stayed calm, her breathing subsided in some way. What happened following was the earache, headache and sore throat. It was so bad she went to Immediate Care. It was the day after, at about 5 in the morning and was still within the 12 hours. It got worse and that was when she went to immediate care and she did not have a fever. When she went into immediate care, she told the doctor what was wrong and her blood pressure was up to like 200/109. It was not good. She was sure it was elevated from night before, but she did not check it because she was trying to stay come. Her blood pressure persisted until she went home. At the doctor's office, it did not go down. He said he had 4 other people here who had a booster shot and have same symptoms as she does. She did not have any information on the other 4 people to complete report on. He looked in her ears and throat and they were fine. She takes Metoprolol and she took her normal medications that morning. He said there is nothing wrong but examined neck and found swollen lymph node on neck. He said it is probably a reaction from the shot. They checked blood pressure again and it was still up. He said this happens with swollen lymph nodes and he checked both ears and listened to her heart and said there is nothing he can do to help except for patient to go home and take 2 Tylenol and rest and it was probably a reaction from the shot. She took the Metoprolol that morning and it did not lower it. She takes it because she has Thyroid and she takes 25mg a day. She takes her medication regularly and believes it brought it down to the 200/109 and it helped, but when she went home again, the doctor instructed her to take another one because that calmed it down and everything else was easing up. She took 2 Tylenol for pain in ear and neck. The Covid test was negative, the Strep was negative, and throat culture was negative. She was fine and could not find anything else other than her symptoms. They did subside after a couple of days. She still has the lump in her neck and all she wants to know if, based on what she reads, is that enlarged lymph nodes a possibility of an effect from the shot. When she went back to primary, the lymph node was still enlarged yesterday. It could be normal for her because she has thyroid issues. She was not going to take the Pfizer COVID vaccine again. Her immunities for the COVID are up and they did test. Her thyroid is wacko. Every month, they are checking for immunities because she was afraid to take the booster shot. She felt she had the mumps, it felt like that. He tested her for it and she did not have it. It was going down and is still there. Her neck hurts. She was trying to get the ultrasound to ensure it is an enlarged lymph node. Her blood pressure is down and was 128/73, which is good. She seems to be doing better except for the lymph node. She noticed lymph node and sore neck right away, and when she went into immediate care the next morning, he examined her and made note of lymph being enlarged that day too.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.