Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: left arm is swollen/over the injection site her arm is swollen like an inch; Over the injection site her arm is swollen like an inch. It is kind of hot to touch and it aches really bad; Over the injection site her arm is swollen like an inch. It is kind of hot to touch and it aches really bad; lymph gland on left side of throat is swollen; feels like lung on left side is heavy and is hard to breathe; feels like lung on left side is heavy and is hard to breathe; bad headache/head will really start hurting; tonsil on left side is swollen; nauseated; feels like she has a fever; feels queezy; This is a spontaneous report from a contactable Nurse (patient). A 61-years-old female patient received first dose of (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: SC3180) via an unspecified route of administration, administered in arm left on 18Aug2021 13:00 (at the age of 61 years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing 4 autoimmune diseases she has 4 auto immune diseases, covid from 2020 to an unknown date she has had Covid twice this past year and got over it, chemo from an unknown date and unknown if ongoing she was getting chemo for 2.5 years every 5 weeks. Concomitant medications were reported as patient was declines to provide. She has been on the same medications for 10-15 years and takes them daily. She was not sure if they are totally relevant. Her PCP knows all the medications that she takes. Her doctor said taking the vaccine should not have any effect on the medications that she is taking. She takes 20 medications. she was taking a generic Tylenol. It was called Assured. They are 500mg. She is taking three every 4 hours. Unable to provide UPC as it is not on the bottle. It was on the box. Lot: P121957, Expiry Sep 2023. The patient previously took azithromycin (Azithromycin 250mg 2 tabs by mouth for 1 day then 1 tablet daily x 4 days. Manufacturer: PEUN. NDC: 50111-787-51, Lot: 7203129, Expiry Nov2021) for covid, methylprednisolon (4mg dose pack. for covid. Historical vaccine includes flu (The last 2 years when she took it, she got so ill that she felt like she was going to die) and felt like she was going to die, flu and experienced ill. The patient experienced left arm was swollen/over the injection site her arm was swollen like an inch, over the injection site her arm was swollen like an inch, it was kind of hot to touch and it aches really bad, lymph gland on left side of throat was swollen, felt like lung on left side was heavy and was hard to breathe, bad headache/head will really start hurting, tonsil on left side was swollen, she has not checked her temperature but felt like she has a fever (doctor said she needs to take 3 doses 28 days apart), reporter seriousness for doctor said she needs to take 3 doses 28 days apart, An hour after getting the vaccine she became nauseated, felt queezy all on 18Aug2021. The events were considered as non-serious. Therapeutic measures were taken as a result of left arm was swollen/over the injection site her arm was swollen like an inch, it is kind of hot to touch and it aches really bad, fever. It was also reported as when she had Covid she was in bed for 6 weeks. They gave her the medications the first time and it hit her again 3 days after she took it. She called the doctor because she had high fever and the same thing happened. They gave her another set of the medication. After 3 days she saw her doctor again. He gave her another prescription to have in case she needed it. Her arm started to hurt 2 hours after she got the vaccine. She keeps taking Tylenol every 4 hours or her head will really start hurting. Patient was not taking other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of the event felt queezy was unknown while the other events were not recovered. Th causality for the events left arm was swollen, lymph gland on left side of throat was swollen, left lung feels heavy on left side and it was hard to breathe, bad headache, tonsil on left side was swollen, felt like she has a fever were reported as related.  Follow-up attempts are completed. No further information is expected.