Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Inappropriate schedule of product administration, Pain, Pain in extremity
Clinical narrative: arm swelling at the site of injection/ puffy injection site; at the injection site and when she looked it is red, feels hot to touch and the area is puffy; itchy, red, hot and puffy injection site/itching at the injection site; at the injection site and when she looked it is red, feels hot to touch and the area is puffy; itchy foot; Fever; Chills; body aches; first dose of the Pfizer COVID 19 vaccine on 23Feb2021 at 10:40 AM in the left arm then received the second dose on 12Mar2021 at 15:00 PM; heat in her crotch; tingling all over her body; sore arm for a day; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer reported for herself that: A 67-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 12Mar2021 at 15:00 (at the age of 67-year-old) as single dose for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. Medical history included ongoing asthma, psoriatic arthritis and stomach irritation all from an unknown date and unknown if ongoing. Concomitant medications included methotrexate (METHOTREXATE) at 2.5mg take six once weekly by mouth for psoriatic arthritis taken for one year; meloxicam (MELOXICAM) at 15mg; once daily by mouth for psoriatic arthritis taken for one year; folic acid (FOLIC ACID) at 3mg once daily per oral for the psoriatic arthritis medications taken for one year; pantoprazole (PANTOPRAZOLE) at 40mg once daily per oral taken for stomach irritation taken for four years; montelukast (MONTELUKAST) at 10mg take once daily per oral taken for asthma taken for 10 years all from an unspecified start date. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 10:40, as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as none. Patient clarified that she received the first dose of the Pfizer COVID 19 vaccine on 23Feb2021 at 10:40 AM then received the second dose on 12Mar2021 at 15:00 PM (as reported on Friday), both in left arm. Within the first two minutes after the second vaccination, she had tingling all over her body and felt heat in her crotch but that went away after ten minutes (on 12Mar2021). On 12Mar2021, the patient had also noticed a sore arm for a day or two right after the shot, but it went away. About 20 hours later into this shot she had fever, chills and body aches that lasted five hours and then she was fine (on 13Mar2021). Last night started with itching at the injection site and when she looked it is red, feels hot to touch and the area is puffy (on 16Mar2021). She experienced some arm, itchy foot, swelling at the site of injection that went away. Patient asked what should be done for the swollen, hot, itchy arm that she had them. Patient's itchy, red, hot and puffy injection site was reported as worsened. Event does not require visit to emergency room or physician's office. The outcome of the events arm swelling at the site of injection/ puffy injection site, at the injection site and when she looked it is red, feels hot to touch and the area is puffy, itchy, red, hot and puffy injection site/itching at the injection site, at the injection site and when she looked it is red, feels hot to touch and the area is puffy was not recovered, heat in her crotch and tingling all over her body recovered on 12Mar2021, sore arm for a day on 14Mar2021, Fever, Chills, body aches recovered on 13Mar2021. itchy foot recovered on 16Mar2021 and first dose of the Pfizer COVID 19 vaccine on 23Feb2021 at 10:40 AM in the left arm then received the second dose on 12Mar2021 at 15:00 PM was unknown.   Follow up attempt are possible. No further information is expected.