Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Infection, Injection site erythema, Vaccination site discolouration, Vaccination site mass
Clinical narrative: she had an infection; redness and warmth came back more another time 3-4 days later.  Caller reported that the area of redness was larger and it had a lot of heat to it.; redness and warmth came back more another time 3-4 days later.  Caller reported that the area of redness was larger and it had a lot of heat to it.; redness and warmth came back more another time 3-4 days later.  Caller reported that the area of redness was larger and it had a lot of heat to it.; Second dose of Covid-19 vaccine scheduled for greater than 21 days; her arm displayed a redness and a little bit of heat to it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 16:30 (Lot number: ER8730) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lymph nodes removed", start date: 2000 (unspecified if ongoing), notes: Verbatim: Lymph nodes removed; "Thyroid removed", start date: May2020 (unspecified if ongoing); "Breast cancer", start date: 2000 (unspecified if ongoing), notes: Verbatim: Breast cancer; "Lumpectomy", start date: 2000 (unspecified if ongoing), notes: Additional Information for Other Conditions: Lumpectomy in 2000; "Keep healthy and on balance" (unspecified if ongoing); "water pill" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroidectomy, start date: 2020 (ongoing); ALENDRONATE taken for bone density abnormal, start date: 08Mar2021 (ongoing); HYDROCHLOROTHIAZIDE taken for diuretic therapy (ongoing); VITAMIN C-75 taken for balance disorder (ongoing). Vaccination history included: Flu vaccine (Caller reported that when she was working, she would get severe sinus infections and colds that would be awful for a few days. ), for immunization, reaction(s): "sinus infections". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second dose of Covid-19 vaccine scheduled for greater than 21 days"; VACCINATION SITE DISCOLOURATION (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "her arm displayed a redness and a little bit of heat to it."; INFECTION (non-serious), outcome "unknown", described as "she had an infection"; VACCINATION SITE MASS (non-serious), INJECTION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "redness and warmth came back more another time 3-4 days later. Caller reported that the area of redness was larger and it had a lot of heat to it.". The event "her arm displayed a redness and a little bit of heat to it." was evaluated at the physician office visit.  Additional information: Patient reported no prior Vaccinations (within 4 weeks) and no Family Medical History Relevant to AE(s). Concomitant Products Unspecified vitamins was (Start: Unspecified Stop: Ongoing. The Concomitant Products Unspecified vitamins reported that she has been taking the vitamins for bone or cartilage for quite some time. The patient taking Concomitant Products Unspecified vitamins (Verbatim): Bone or cartilage. Dates for Concomitant Products Multivitamin was (Start: Unspecified Stop: Ongoing). The Concomitant Products Multivitamin reported that she began taking the multivitamin about a month ago. The patient taking Concomitant Products Multivitamin (Verbatim): Bone doctor said to take a multivitamin. Concomitant Products Unspecified vitamin for the eyes was (Start: Unspecified Stop: Ongoing). Concomitant Products Unspecified vitamin for the eyes reported that she has been taking the vitamin for her eyes for quite some time. The patient taking Concomitant Products Unspecified vitamin for the eyes (Verbatim): Eye doctor recommended Reporter received the first dose of the Covid-19 vaccine on 27Mar2021. Reporter reported that her physician was dancing around saying what the caller should or should not do regarding the second dose of the Covid-19 vaccine. Reporter reported that her appointment for the second dose of the Covid-19 vaccine is scheduled for next Tuesday, 20Apr2021. Reporter reported that she has large palms and long fingers. Reporter reported that the area of redness and warmth was close to 6 inches, maybe a little less, and not quite as wide as 4 of her fingers together would be. Reporter reported that her arm was not hurting her but she was stunned when she saw the area of warmth and redness on her arm. Reporter reported that she didn't notice the redness or warmth on her arm for a few days, but then the redness and warmth came back more another time 3-4 days later. Reporter reported that the area of redness was larger and it had a lot of heat to it. The Reporter reported that her doctor did not think that she had an infection and asked if the Reporter had taken Benadryl. The Reporter reported that she had not taken Benadryl as she does not do that kind of stuff. Reporter reported that her physician instructed her to take some Benadryl if her arm was bothering her. Reporter reported that her physician then said that the Reporter did not have to take Benadryl. Reporter reported that her physician recommended that she take a couple of Benadryl before her second dose of the Covid-19 vaccine. Reporter inquired if there was any necessity that she should be looking for that she will be getting a worse reaction with the second dose of the Covid-19 vaccine. Reporter reported that she didn't get sick following the first dose of the Covid-19 vaccine, that her arm just had some heat on it. Reporter inquired if it was safe for her to get the Covid-19 vaccine without medicine. Reporter reported that the appointment for her second dose is scheduled for 20Apr2021, but that she would be able to go Saturday, 17Apr2021 as the vaccination facility has availability. Redness and heat on arm: Reporter reported that the heat and redness on her arm appeared about the middle point of the waiting period between Covid-19 vaccine dose. Reporter reported that the redness and heat on her arm subsided after it was first observed and she did not notice anything for 2-3 days. Reporter reported that when the redness and heat came back, the heat was much more than what it was when it first appeared. Reporter reported that the redness and heat disappeared again a day or so later. Reporter reported that she didn't take any medication to treat the redness and heat on her arm, such as Tylenol or Benadryl. Reporter reported that her doctor informed her that the Reporter could get the redness and heat on her arm even worse following the second dose of the Covid-19 vaccine.   No follow-up attempts are possible. No further information is expected.