Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Injection site pain, Neck pain, Pain
Clinical narrative: Soreness of the arm; A little tiredness; Generally not feeling well; her shoulder is killing her; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EW0183), via an unspecified route of administration on 22Aug2021 at 04:00 (at the age of 74-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. Medical history included suspected food poisoning, iodine allergy, Dye allergy (all from an unknown date and unknown if ongoing). The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as None. No Additional Vaccines were administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect. On an unknown date, the patient experienced shoulder killing. On 22Aug2021, the patient experienced not feeling well, a little tiredness, Soreness of the arm.It was reported that Was in the emergency room because she had been vomiting and throwing up for 4 hours and was taken by ambulance and they ran bloodwork, a CT scan, and they actually did not give her a diagnosis, but suspected food poisoning. Went to the emergency room because she was sick and had thought she had possibly had Covid. It was negative and if having Covid was anything like this or worse she decided to get a Covid 19 shot. They offered it to her and she made the decision to get it there because she did not want to be sick like this again, although it wasn't Covid. was in emergency room prior to covid 19 shot for suspected food poisoning. She has since improved. Was in emergency room with suspected food poisoning before administration on Covid 19 vaccine. No further details provided. Received her first dose of the Covid 19 vaccine on 22Aug2021 at around 4am while at the emergency room. Unable to provide the NDC, expiry of dose, but provides lot number of EW0183. Had no other vaccines that same day, none 4 weeks prior and no problems with vaccines in past. Has had allergic reaction to IV things put into her in past like Iodine. She also had consulted her family physician about the immunization before she went ahead with it. Goes back to say she has had allergic reaction to like having dye at the eye doctors and had whatever it was had dye in it and she had an allergic reaction. Unable to provide NDC, Lot, or expiry for Iodine or other products given by IV or with dye in it. No further details provided. States right after the vaccine she had the basic soreness of the arm, a little tiredness, generally not feeling well for a couple of days. Which the arm pain has never gone away and steadily gotten worse. Is going to the doctor tomorrow because her arm is killing her and her shoulder is killing her. Has been using Ibuprofen 800mg and Extra Strength Tylenol 500mg and they are not making it feel any better. Unable to provide the UPC for the Extra Strength Tylenol, but provides lot number of AEA025, which she states she can't see real good because it's in black and an expiry of Apr2025. Says it's distributed by Johnson & Johnson. Unable to provide the NDC, Lot, or expiry for the prescription Ibuprofen 800mg stating it's in an orange pharmacy bottle. Is going to put on a heating pad to see if that will ease it. No further details provided. Is concerned because she is supposed to get a second shot next week and this is giving her pause to do that because it's (arm pain) getting worse than better with the medication. No further details provided. Got the COVID 19 shot through withheld, goes through withheld for her other medical issues. No further details provided. Did see on 31Aug2021 the PA at her doctor's office for a follow up check up and discussed what she had had and mentioned her arm was still sore. They said something like it will take a while to get better, but this doesn't feel right. Thought she should report this. Asks if Pfizer gives out advice. No further details provided. Has been using Ibuprofen 800mg and Extra Strength Tylenol 500mg and they are not making it feel any better. Unable to provide the UPC for the Extra Strength Tylenol, but provides lot number of AEA025, which she states she can't see real good because it's in black and an expiry of Apr2025. Says it's distributed by Johnson & Johnson. Unable to provide the NDC, Lot, or expiry for the prescription Ibuprofen 800mg stating it's in an orange pharmacy bottle. Is concerned because she is supposed to get a second shot next week and this is giving her pause to do that because it's (arm pain) getting worse than better with the medication. The adverse event did not result Emergency Room. The patient was visited to emergency room for Soreness of the arm. Therapeutic measures were taken as a result of adverse event and treatment included Ibuprofen 800mg and Extra Strength Tylenol 500mg.Product strength and count size dispensed: 800mg, 500mg.The outcome of the events was not recovered.