Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Malaise, Mutism, Nausea, Pain
Clinical narrative: trouble swallowing; she commented it is like she cannot talk either; does not feel well at all; Arm hurt quite a bit; Getting flu like pains; it starts from my neck and it goes down to my ankle and I have to take pain pills every 4 hours because the pain is so severe; nausea; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6202, Expiration Date: not reported) via an unspecified route of administration in left arm on 19Feb2021 15:00 as dose 1, single for COVID-19 immunization (for health) (at the age of 85-year-old). Medical history included arthritis from 2020 to an unknown date. The patient previously took flu, shingrix and experienced rash. She mentioned when she was young she lived in an area where the Flu was common. She would get Flu Shots each year but stopped because she was now allergic to them. She had a reaction each time to the Flu Shot. Therefore, for several years she did not get any. She had not had a Flu Vaccine for like 30-40 years. She remembered as a child had a reaction to it. It was like she had the Flu after the injection. She was afraid of possible reactions so had been years since gotten it. She confirmed she had no lot/exp/NDC to provide from the Flu vaccine. She avoided vaccines for the most part. Last year she had as clarified the Shingles vaccine. Mentioned this was a condition where people break out from rashes with it. She confirmed she had no reaction to the Shingles vaccine. The patient's concomitant medications were not reported, patient took a lot of medications and did not think they were relevant, because had no change in her medication at all. She taken them for many years, the same medications. Patient had no prior vaccinations within 4 weeks. There was no history of previous immunizations with the Pfizer vaccine. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient experienced arm hurt quite a bit on 19Feb2021, getting flu like pains; it starts from my neck and it goes down to my ankle and i have to take pain pills every 4 hours because the pain is so severe on an unspecified date in Feb2021, nausea on an unspecified date in 2021, trouble swallowing, she commented it was like she cannot talk either, does not feel well at all on an unspecified date. It was reported that, 4 days after the vaccine she had severe pains in the back of her neck down to her spine. She had to take Tylenol every four hours for the pain. She was also nauseous at times and had trouble swallowing. She did not felt well at all. She went to her PCP and was advised to see if the cause of her events were from the COVID vaccine as they did not have any information at all and could not find anything specifically wrong with her during the visit. She commented it was like she could not talk either. She was scheduled to get the second dose on 12Mar2021. She was sceptical to get the second dose due to the effects. She was concerned and wanted questions answered before the 12th. She was confused and wanted to determine the cause of pain. She added making decisions was difficult for her. She saw the PCP the other day and they were concerned because they did not know what was wrong with her. She was advised to see if the shot effected her body. She mentioned her arm hurt quite a bit after the vaccine. She had been exercising it. This started several hours after getting the shot. This arm pain was a 24hr thing. She then mentioned 3-4 days after getting the pain the severe pain was noticed. It was only relieved with Tylenol. She took two Tylenol every four hours to ease the pain. The pain was like being pounded with a bat. She could not leave the house anymore. She was afraid to leave due to pain. The nausea came and went. It was not constant. She first noticed maybe 7-8 days after the vaccine. It was not constant like the pain in her back. She could not live with the back pain. The doctor wanted blood work done, but she could not get it done until after the second shot. She wanted to get blood work done before the second shot, but the clinics were very busy and she could not get in any sooner. She also added, she has been nauseous from the nerves. She mentioned she was on medication for the nerves, but name of medication was not specified. She added the nauseous could also be from the pain and/or could be causing the pain. She was so upset with her physical condition. This could be causing the nausea. Patient Wondered if her reaction was related to arthritis. When saw the doctor 2 days ago doctor reminded her she had arthritis. She did not know if this pain was from arthritis or COVID shot. Patient was trying to diagnosis herself. The trouble swallowing and nausea were related to one another. She added she took nerve medication, like a nerve relaxer and it helped with the pain. Name of nerve medication was not specified. she had been drinking water and it helped with the trouble swallowing, nausea and pain. No AEs required a visit to the emergency room and required visit to physicians office due to severe pain. She thought it was a coincidence this pain started shortly after getting the COVID shot. She was unsure if related to arthritis. At time she could not wait until the next Tylenol scheduled dose. She did not want to go to the ER. A lot of people died and she was afraid and cautious of going to hospital and places she went. Therapeutic measures were taken as a result of events. Patient mentioned she took a Rolaid, then clarified it was something like a Rolaid. This was to help and over the counter. The outcome of the events nausea, she commented it is like she cannot talk either, does not feel well at all unknown, getting flu like pains; it starts from my neck and it goes down to my ankle and i have to take pain pills every 4 hours because the pain was so severe, trouble swallowing not recovered. Arm hurt quite a bit was recovered on an unspecified date in Feb2021 and duration of reaction/event was 18 day.  No follow-up attempts are possible. No further information is expected.