Reporte zur Charge EN06201

Symptomtext

eye was swollen and itchy for 4 days; eye was swollen and itchy for 4 days; mildly sore arm; Left arm itching, red, and swollen; Left arm itching, red, and swollen; Left arm itching, red, and swollen; her arm was sore and swollen at the injection site for a couple of days; her arm was sore and swollen at the injection site for a couple of days; This is a spontaneous report from a contactable consumer. A 74 age female patient (unit- unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN06201), via an unspecified route of administration, administered in left arm on 22Feb2021 13:30 (at the age of 74-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. When she gets the Flu vaccine sometimes gets a sore arm. One time she felt like she had flu symptoms, but it didn't last long and was right after the flu vaccine. It varies from time to time. Has no NDC/Lot/Exp for any past Flu Vaccine. The patient's appointment was at 13:20 so somewhat after that. She left the facility at 13:50, which was after waiting 15 minutes. Didn't have any kind of allergic reaction. The patient received the 1st dose of the Pfizer vaccine on a Monday, 22Feb2021 at 13:30 and experienced a mildly sore arm that evening that lasted for about 24 hours as it went away the next evening. Yesterday, she got up and noticed that her arm was itching, red, and swollen. The symptoms are still persisting but the itching was going away. It doesn't really hurt, but it hasn't gone away. Yesterday is a week from the COVID Vaccine. It is quite unusual to have a reaction a week later. On 01Mar2021, She states that her arm was sore and swollen at the injection site for a couple of days and then the soreness went away. A week later her eye was swollen and itchy for 4 days and then those symptoms went away as well. She noticed yesterday that her arm started getting a little sore again and she noticed there is a "bump" where the vaccine was given and notes this as "feeling swollen." She also states that she has had similar reactions to the flu vaccine in the past with her arm being sore and swollen at the injection site but she has never experienced those symptoms returning once they have gone away. Her arm was sore for 24 hours. A week later her arm was swollen and had a red area and it itched. She called Pfizer a week ago yesterday. She didn't know why it was so long for that reaction. They told her it could be seven to eight days for that reaction. It was like that for 4 days. Yesterday morning she woke up and it was itching and swollen, but it was not as swollen as it was previously. There was a pinkish red area. It came back again after 2 weeks. Her concern is whether she can get the vaccine. She could get it in the other arm. She is supposed to get the second vaccine on 18Mar2021 considering her recurrence of injection site swelling and soreness. The clinical outcome of the event eye was swollen and itchy for 4 days was resolved; her arm was sore and swollen at the injection site for a couple of days was resolved on 23Feb2021; while that of left arm itching, red, and swollen was not resolved; mildly sore arm was unknown. Description of Product Complaint: One time she felt like she had flu symptoms, but it didn't last long and was right after the flu vaccine. Has no NDC/Lot/Exp for any past Flu Vaccine. She got a letter yesterday from Pfizer that said she filed a complaint. She doesn't consider it a complaint, but considers it a concern. Reference number: 5709643. There is a complaint number but it is very long and the reference number should be enough she would think. On the vaccine card she was given it says one dose. No follow-up attempts are possible. No further information is expected.