Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gait disturbance, Hypersensitivity, Muscle swelling, Pain in extremity
Clinical narrative: allergic reaction; severe pain on the left heel of the foot; got the shot on her left deltoid then right after had semi-serious pain; left deltoid is real swollen, kind of warm; left deltoid is real swollen, kind of warm; she could hardly could step; This is a spontaneous report from a contactable (nurse). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 21Jul2021 12:45 (Batch/Lot Number: FA7484; NDC number: 59267-1000-01) as dose 1, 0.3 ml single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient has no history of previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect and no prior vaccinations within 4 weeks. The nurse reported that her niece (patient) received shot number 1 on "19Jul2021" on her left deltoid. Right after, she had a lot of pain, semi-serious pain; then about a day later (22Jul2021), the pain on the left deltoid was gone and she's having a severe pain on the left heel of the foot and when she looked at both deltoids, the left is real swollen and kind of warm on Jul2021, and today she's complaining of pain in the left heel, "she put her finger and pressed it and when she put her thumb on her left heel and feel it, it's a 1/4 inch" and it is really painful for her. She really thinks this is part of the side effects or an allergic reaction to it. There's no bruising or nothing on the foot, just a really bad pain. The reporter is a nurse and she's looking at all the signs and symptoms and she's never seen this and wanted to report it since it's kind of new and thinks it is important to gather all these signs and symptoms. The nurse confirmed the patient got the Covid 19 vaccine Pfizer on 21Jul2021, the first shot. She reported that the patient's arm pain is subsiding, but the heel is getting painful. The deltoid pain where she got the shot, it was really minimal and now the pain is on the left heel. There is no pain on the left deltoid. It was a pain because of the shot and it's not painful or uncomfortable anymore. Patient got the shot on 21Jun2021 and there was pain on the deltoid; 24 hours later which is on 22Jun2021, the left deltoid is subsiding, no pain and pain now is on left heel. Patient put it in the hot water and took Benadryl and Advil and the pain is not as bad but it's still there. The patient has to avoid the heel when she takes steps. Before the patient took all the warm water and Benadryl, she could hardly step on Jul2021. She really wants it on record because they are still in a phase of collecting information on signs and symptoms and this is unusual, she's looking at all the symptoms and it's not on here, it looks like a transfer of pain from left deltoid to left heel. The outcome of the event "got the shot on her left deltoid then right after had semi-serious pain" was recovered on 22Jul2021, "severe pain on the left heel of the foot" was not recovered while the other events were unknown.; Sender's Comments: Based on close temporal relationship the causal association between the events vaccination site pain, pain in heel, muscle swelling, localized feeling of warmth and she could hardly step (gait difficulty) and the usage of the vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.