Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: rash was swollen, red, inflamed, and was in her right arm right in the middle which she verified is also where she received her injection; rash was swollen, red, inflamed, and was in her right arm right in the middle which she verified is also where she received her injection; rash was swollen, red, inflamed, and was in her right arm right in the middle which she verified is also where she received her injection; rash was swollen, red, inflamed, and was in her right arm right in the middle which she verified is also where she received her injection; Rash/the rash was swollen, red, inflamed/The rash is ongoing and is about the same except that it is darker; fever that spiked for a couple of days/fever got up to 101; injection site pain; arm was sore; This is a spontaneous report from a contactable female consumer (patient).  A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0169; Expiration Date: 31Aug2021), via intramuscular route, administered in right arm (as reported right middle arm) as dose 1, single on 22Apr2021 08:20 (at the age of 54-year-old) for covid-19 immunisation at hospital. Patient's Medical History (including any illness at time of vaccination) Illness/AE was reported as none. Concomitant medications were not reported. No patient's medical History (including any illness at time of vaccination) Illness/AE. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as no. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Caller received the Pfizer COVID vaccine on 22Apr2021, and she now had a rash that won't go away and stated she will call her doctor. She had a band-aid on her arm for about 24 hours and she took it off when she got in the shower. She noticed the rash on 23Apr2021 about 7am, she remembered this because she started work at 7:30AM. She described the rash was swollen, red, inflamed, and was in her right arm right in the middle which she verified was also where she received her injection. She clarified injection site as the middle of her right arm, right below the length of the t-shirt. The rash was ongoing and was about the same except that it was darker on 23Apr2021. She had pictures of the rash and was agreeable to provide them. Caller also reported she had a fever that spiked for a couple days, and fever got up to 101. She experienced a slight temperature around 8:30pm on 22Apr2021 and she remembered this because she went to bed early which was out of her routine. Caller also reported her arm was sore on 22Apr2021. She specifically stated it did hurt, she's not going to lie, and when asked when the pain started, she reported when she got the vaccine. She's not sure exactly when the injection site pain went away because she was caught up with everything else but reported that it was completely resolved as of today (at the reporting time). States she needs to call her doctor to see if they will give her something to treat this rash because she doesn't want it to continue to go untreated. Adverse events did not require a visit to emergency room and physician office. Therapeutic measure was taken as a result of adverse event fever was Tylenol. She was concerned about getting the second one and will talk to her doctor about all of this. The patient underwent lab tests and procedures which included body temperature: 101 on 22Apr2021. Other relevant diagnostic and confirmatory testing, lab work, treatments was reported as none. Therapeutic measures were taken as a result of fever that spiked for a couple of days/fever got up to 101 she took Tylenol and an alcohol bath, and it finally broke on Saturday. At the time of this report, the outcome of event arm was sore, injection site pain was recovered on unspecified date in 2021 and fever was recovered on 24Apr2021 and all the other events were not recovered.  No follow-up attempts are needed. No further information is expected.