Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Incorrect route of product administration, Off label use, Pain in extremity, Product administered at inappropriate site
Clinical narrative: painful at the injection site; a little tired; it was not administered in the deltoid muscle, but rather in the bursa or the joint /he missed her deltoid, went too high; it was not administered in the deltoid muscle, but rather in the bursa or the joint /he missed her deltoid, went too high; it was intra-articular or intra-bursal; it was painful, pain traveled down her arm into her fingers/ipsilateral hand pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Jan2021 09:00 (Lot number: EL3248, Expiration Date: 30Apr2021) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "coronary artery disease", start date: 2020 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EK5730, Expiration date: 31Mar2021, Vaccine administration time: Around 10:30 am., Route: Injection, Anatomical location: Left deltoid, arm), administration date: 21Dec2020, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) all with onset 15Jan2021 09:00, outcome "unknown" and all described as "it was not administered in the deltoid muscle, but rather in the bursa or the joint /he missed her deltoid, went too high"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Jan2021 09:00, outcome "unknown", described as "it was intra-articular or intra-bursal"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "painful at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 15Jan2021, outcome "recovered" (18Jan2021), described as "it was painful, pain traveled down her arm into her fingers/ipsilateral hand pain"; FATIGUE (non-serious) with onset 16Jan2021, outcome "unknown", described as "a little tired".  Additional information: The patient did not have any family medical history relevant to adverse events. The patient stated that she did not take NSAIDS or anti-inflammatories. No additional vaccines were administered on same date of the Pfizer suspect. The facility where the most recent COVID-19 vaccine was administered was Hospital. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose as an injection in the left deltoid, arm. The patient received the second dose of the Pfizer COVID 19 vaccine two weeks later the first dose and was injected into left shoulder, was painful, little tired and stated that it was not administered in the deltoid muscle, but rather in the bursa or the joint instead. The patient stated she was turned to the side, standing up and the next thing she knew was he gave it. It was intra-articular. The person administering the vaccine said that's where he was taught to give it and then did it anyway, way above the deltoid. It was intra-articular or intra-bursal. It was very painful at the injection site and she had ipsilateral hand pain. No other deficits. She also knew of a radiologist that had their dose administered in the wrong place. She wanted to know if she was fully vaccinated with the second dose being administered incorrectly. The caller stated that when she got it, the second dose, the patient made the comment that she thinks the person administering the injection, was doing it in the wrong place. The caller stated the answer was that he responded (person administering the vaccine) that he knew what he was doing. The caller stated that he didn't knew and he went into the joint. The caller stated that he missed her deltoid, went too high. The caller wanted to know whether she has total immunity. The caller stated that they think it went into the joint space. The caller stated that she spoke to the head of the department also had the same problem. It actually hit the nerve. She wanted to know if she should get another dose. The patient stated as soon as it happened, it was the most painful injection of her life. It traveled down her arm into her fingers. She had no systemic symptoms from the shot. She was concerned about her immunity being addressed since it was intra articular. The patient stated that she had pain in her arm for a few days, it was the worst shot of her life. The patient stated that it was as if she got the flu vaccine, only it was more painful because of where it was given, the location. The patient stated no swelling, redness, no fever, nothing systemic just sore. She was a little tired the second day. She was calling to ask if she had compromised immunity now. She had suboptimal immunity, she needs another dose. The adverse event did not require a visit to Emergency Room or Physician Office. No relevant tests were done. There was a Product Complaint.  No follow-up attempts are possible. No further information is expected.