Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: hurt more; rash itching; redness; Developing the short sight like a rash and it's you know kind of puffy and hot; Developing the short sight like a rash and it's you know kind of puffy and hot; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; at the injection site is itchy, rash and swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female consumer (patient) reported that: A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0177; Expiration date: Unknown), via unspecified route of administration injected in upper left arm on 27May2021 as single dose for covid-19 immunization. The patient medical history included immediate allergy to penicillin. The patient's historical vaccine included first does of bnt162b2 on 06May2021. Past drugs included penicillin and fexofenadine (ALLEGRA). The patient called to inquire that she had taken fexofenadine (ALLEGRA) in the past and whether she can put diphenhydramine (BENADRYL) on it. She was responded from the attached CONS. The patient stated that she had received the second dose of bnt162b2 on 27May2021. She stated that on an unspecified date in 2021, it hurt more, and she was experiencing rash and itching. She said, the week prior to that little bumps on legs which was last Tuesday and dose was given on Thursday. She was asking if this was a reported adverse event greater than Day One post vaccination. The patient was responded from attached and Full EUA Prescribing Information 6.1 Clinical Trials Experience LAB-1457-9.0 Revised: 19May2021. The patient stated that she had called three times and was given VAERs information. The AE was E-transmitted and she was referred to HCP. The report was not part of study or program. The patient stated that she had developed short sight like a rash and it was kind of puffy and hot on an unspecified date in 2021. The patient did not specify seriousness of the events itchy rash, puffy skin and feeling hot. The patient stated that she got her second shot last Thursday, which was on 27May2021 and she noticed some redness and stuff, but she didn't get sick at all after the next day or anything like that, but today she was developing the short sight like a rash and it was kind of puffy and hot. She did not know if that was normal. She inquired whether most people will get the reaction right away. She confirmed that it was Pfizer COVID-19 vaccine. When informed about the Pfizer medical information department for the concern, the patient stated that they gave her a number and said to press 3 already. She was informed that after dialing the number, she needs to press option 3 to reach the department. The patient stated that that's what she did and then they asked her for another option and then another option. So, she pressed option 3, then option 2 and then option 1. The patient was informed that in order to reach the Pfizer Medical Information Department she needs to press option 3 and if she pressed option 1 then she would reach  Department. The patient stated that she did exactly the same and that's how she got connected to the Pfizer Department. She was informed the role of Pfizer drug Safety Department and asked for permission to probe questions, upon which the patient replied that she just wanted to talk to somebody who could tell her whether it was okay. She wanted to check if anybody has had it and said that she was actually at work and was trying to get to the Pfizer drug Safety Department before 8 o' clock. The patient was provided with timings of Pfizer medical information department as 8 AM to 8 PM on Monday to Friday and 9 AM to 3 PM on Saturday and Sunday, EST. The patient was unwilling to complete the report. Hence, limited information was available. The patient called again and stated that she experienced "injection site is itchy, rash and swollen" on an unspecified date in 2021. She was unsure about the lot number whether it was EW "O" 117 or EW "zero" 117. Expiry date of the covid-19 vaccine was unknown. The patient stated that she called because she had the second shot on last Thursday, and she did not know because she did not have any reaction to it, but today (on an unspecified date in 2021) "at the injection site is itchy, rash and swollen". She wanted to know whether it was normal. She confirmed that the shot was of Pfizer Covid 19 vaccine. She confirmed her second shot was on last Thursday, on 27May2021. She stated that the first shot was three weeks apart to that. She did not recall the exact date, but believed it to be Thursday. She stated it was 06May2021, which was 21 days apart. She was unsure of the lot number whether it was EW, zero or O, 177. The outcome of the events were unknown.  Further probing was not done hence limited information available over the call.