Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: uncomfortable; itching at the injection site but it was also all over her body; itching at the injection site but it was also all over her body; redness at injection site; swelling at injection site; left arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 16:30 (Lot number: FA6780) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shingles" (unspecified if ongoing), notes: she was probably 11 or 12, well between 11 and 13 years old, she did have shingles. The patient's concomitant medications were not reported. Past drug history included: Bactrim, notes: The only thing she is allergic to is Bactrim. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", PRURITUS (non-serious) with onset 13Aug2021, outcome "recovered" (16Aug2021) and all described as "itching at the injection site but it was also all over her body"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; VACCINATION SITE ERYTHEMA (non-serious) with onset 12Aug2021, outcome "recovered" (20Aug2021), described as "redness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 12Aug2021, outcome "recovered" (20Aug2021), described as "swelling at injection site"; PAIN IN EXTREMITY (non-serious) with onset 11Aug2021, outcome "recovered" (20Aug2021), described as "left arm sore". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pruritus, pruritus, discomfort, vaccination site erythema, vaccination site swelling, pain in extremity.  Additional information: Reporter stated, there was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. If it was that bad, she would have gone to the physician's office. She had watched it for a couple of days. If it had gotten worse, she would have gone to the ER and if the itching got worse. She knew that if it didn't subside in 24 hours she would go ahead and go. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was none. Does not take vaccinations. Patient Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to AE(s) was no. Relevant Tests was none. The only thing is that when she was probably 11 or 12, well between 11 and 13 years old, she did have shingles. That was the other thing that bothered her. She wondered if itching caused or messed with anything. She only had shingles the one time. Even through her pregnancy, it never bothered her again. The other thing she did think about was looking for rashes. She was hoping not to reactivate that. she was with the pharmacist "about to get the vaccine" and reported when she received the 1st dose of the vaccine she had itching at the injection site but it was also all over her body. She stated it was not "intense itching" but it was noted to be "uncomfortable." Reporter reported having no hives. The pharmacist advised the reporter to contact Pfizer MI prior to getting the 2nd dose of the vaccine today due to her having itched, that was not at the injection site only & was noted to be all over her body. PQC was not present. Reporter seriousness for redness at injection site was Unspecified. Reporter stated she was calling regarding the Pfizer Covid-19 vaccine. Apparently, when she took the first vaccine 11Aug2021, she was supposed to report any side effects. She was reporting it today because as she went to get the second vaccination, she was told that because she had a reaction, they did not want her to take it. They wanted her to communicate with her doctor first. They asked her if she reported it and she said that she was given no number to report anything. It was in the beginning of Aug2021. Reporter stated to make sure it is notated that she was not told to contact us before the shot was administered 11Aug2021. Around 13Aug2021, she started experiencing swelling at the injection site and redness at the injection site. Probably around 14Aug2021, it started itching. It was not a rash, just the skin all over was really itchy all over her body, not just that side, but all over. It lasted about 3 days. Clarified that the swelling and redness at the injection site started the day after, on 12Aug2021 and lasted up until 20Aug2021. Itching all over her body: Was from 13Aug2021 to 16Aug2021. It was all over her body, and in her head and the other side of her body. She was looking to see if anything else would come up, but the skin was itchy for 3 days. Treatment was reported took Tylenol before she went and had the injection. She took Tylenol about an hour and a half before she went on 11Aug2021. She took Tylenol at night just to make sure she did not get any other symptoms throughout the day. From 11Aug2021 until 16Aug2021, she was taking Tylenol because she thought it would help with the itching as well. She also had a sore arm. That was the other reason she continued to take the Tylenol. By 16Aug2021, the symptoms had subsided and did not really need the Tylenol. It was just a little swollen and was not as bad. The arm was kind of sore, 11Aug2021 until 20Aug2021 about 9 days. The soreness was in the left arm. Stated that the people she got the vaccination from did not tell her to contact us. They asked her why she did not report it and she stated she was never told she had to. When she went to have the second one done, they told her to come back tomorrow because it would be the 21st day. She was going to go ahead and take it but they told her to come back tomorrow. She did not care to take the second one if she does not need to or if it is not safe to take it. She does not mind to not take it if it is going to put her in the hospital with an allergic reaction. Her job is acting like she does not want to take it. If she did not want to take the second one, she would have never taken the first one. Concomitant medications was reported as, does not take any medications regularly (not specified whether took at the time of vaccination, hence not captured). The only thing she is allergic to is Bactrim. She asked the lady on the phone if any ingredients of this was in the vaccine. The only time since then, where she itched like this was then. She had to ask if there was any Bactrim in it. She was allergic to Bactrim and had the same itching as she had with that. It did not feel as bad but she could not say that it was not in in it. The lady said it did not have any traces of it in there. It could have absolutely had that in it. Clarified that the lady the reporter was referring to was from the CDC. She had the allergic reaction about 8 years ago. That is how she learned she was allergic to it. Tests was reported as, no, not for a while, not related to the skin reaction. The last blood work she had done was all fine. Event did not require any AE(s) require a visit to, Emergency Room. Physician Office visit was not required. The case was reported as, non-serious.  Follow-up attempts are completed. No further information is expected.