Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling, Ultrasound scan
Clinical narrative: pain and left foot swelling; pain and left foot swelling; leg pain following the second first vaccine; The vaccine her mother was given on Thursday 04Nov2021 was her mother's first dose/second shot she received on Tuesday, 09Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 14:00 (Lot number: LiFG3527, Expiration Date: Feb2022) at the age of 83 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (ongoing), notes: Verbatim: Diabetes; "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure; "Hip surgery", start date: 03Aug2021, stop date: 10Nov2021, notes: Hip replacement surgery. Her mother has been recovering from that well. She was healing nicely and was not having any pain.; "flu shot", start date: 13Oct2021, stop date: 13Oct2021, notes: Anatomical Location of Arm: Left Arm; "Depression" (unspecified if ongoing); "Low iron level", start date: Feb2021 (ongoing), notes: Pertinent details: See Dr. has has a colonoscopy and an endoscopy; "Hip pain", start date: Nov2021 (ongoing), notes: She saw two surgeons one surgery was cancelled because of the low iron levels.; "Leg pain" (ongoing), notes: off and on before and after the surgery. Nurse practioner gave her cream to put on her joints. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 18Oct2021; METFORMIN taken for diabetes mellitus (ongoing); GLIPIZIDE taken for diabetes mellitus (ongoing); PROZAC taken for depression (ongoing); CALCIUM (ongoing); LISINOPRIL. Vaccination history included: Bnt162b2 (1st Dose, location: right arm, Batch/lot number: unknown, Time: 1400, Expiry date: unknown), administration date: 04Nov2021, when the patient was 83 years old, for COVID-19 Immunization, reaction(s): "Given dose of vaccine that had sat out for 30 minutes too long", "Nurses gave her mom an expired vaccine on Thursday", "Aches and pains in lower back and legs", "Aches and pains in lower back and legs". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Nov2021, outcome "unknown", described as "The vaccine her mother was given on Thursday 04Nov2021 was her mother's first dose/second shot she received on Tuesday, 09Nov2021"; PAIN IN EXTREMITY (non-serious) with onset 11Nov2021, outcome "not recovered", described as "leg pain following the second first vaccine"; PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 12Nov2021, outcome "not recovered" and all described as "pain and left foot swelling". The patient underwent lab test and procedure which included Vascular lab (ultrasound) on 12Nov2021 showed no blood clots. Additional information: This consumer (patient's daughter) reported for a 83-year-old female patient (reporter's mother). After the shot/first covid-19 vaccine on 04Nov2021, patient had severe leg pains/legs hurt after the first vaccination for three days (from 05Nov2021 to 08Nov2021). She rested and did not want to see a doctor. On 11Nov2021 after the second first vaccine, patient experienced leg pain, ongoing (Made a doctor's appointment) and on 12Nov2021 pain and left foot swelling, ongoing for which Dr. (Name withheld) ordered a vascular lab to check for blood clots. An ultrasound done 12Nov2021 showed no blood clots. She is still experiencing leg pain. The left one hurts the worse. Adverse events did not result in Emergency Room or physician office visit. Other concomitant medications included unspecified Blood pressure high has been ongoing for a long time and her mother is weaning off of an unspecified pain medication since the hip surgery. After surgery, patient did physical therapy with a therapist that came to her home. She takes an iron pill, a pill for acid reflux and pain medicine. She is supposed to stop the pain medication by the end of the month. She also takes lisinopril. She stopped taking. Clinical course: Her mom had gotten the vaccine last Thursday and then she was improperly given another dose on Tuesday. Reporter states that her mother's doctor's office didn't contact anyone. They didn't contact the CDC, Pfizer, or the local health department. They just decided on their own to re-administer the vaccine. They acted like she needed to come in really fast on Tuesday and get it done without discussing it with anyone. They are learning after the fact that the office should've contacted Pfizer for guidance and that her mom should've been given the opportunity to decide if she wanted it for herself. Herself and her sister are on all of her mother's HIPAA forms at the doctor's office. When asked for consent to contact the HCP the reporter states that the HCP keeps changing what they are saying. One of the nurses gave her mom an expired vaccine on Thursday. That nurse then called the reporter mom and made it sound urgent and said the doctor had given permission for the shot to be re-administered on Tuesday. She didn't know it was the nurse who had called her mom she thought it was the doctor or one of the people that he has on staff that call about appointments. The nurse led the reporter mom to believe that the doctor was up on the protocols. They found out afterwards that the doctor did not know about the second shot. Then today, the office said that the doctor did know about the second shot and the office keeps changing their story. Reporter does know that they didn't contact the CDC, Pfizer or the Health Department like they were supposed to. Reporter called the CDC herself and they have no record of a report. The nurse only talked to a pharmacist that is part of the local hospital system. The pharmacist said that nurse to give the reporter mom the opportunity to get the vaccine again if she wanted to. None of the protocols were taken care of. States that the doctor's office seems to be trying to cover their tracks. Reporter states that they are supposed to be meeting with the doctor's office. They told her mom that vaccine had sat out for 30 minutes too long and that is why they had to re-administer the vaccine to her on Tuesday, 09Nov2021. Reporter states that her mom likes her doctor and always wants to do as he says. Both the vaccines were administered in her mother's right arm. Reporter stated that her mother should've gotten the second one in her other arm. Reporter was just trying to figure out exactly what happened but seems like they are trying to cover things up. Patient is scheduled to receive a third dose on 12Nov2021. We want to know if she needs it and if yes, should be a smaller dose. Patient was given a first Pfizer vaccination on 04Nov2021. The medical assistant who gave her the first shot called her mom on 09Nov2021. She told reporter mom she needed to come into the office for the second first shot. She said that the first shot sat out 30 minutes too long. When we got to the office reporter asked her if my mom should get another first vaccination so close to the other one, she said Doctor was on top of it. She said reporter mom shouldn't have any side effects. They never saw a doctor, and no one told us how it was determined that her mom needed another shot. They were given vague answers. Before giving patient the second first shot, she said that it had been out 10 minutes too long. They have tried to talk to the people involved at Dr. (Name withheld) office and (Workplace name withheld) staff to find out the reason for the second first shot and why it wasn't explained better to her mom before it was given. They also wanted to know how much she was given on 04Nov2021 and 09Nov2021. They have also been unsuccessful in getting the lot number for the first shot and the expiration date, (Name withheld) took the first vaccination card from my mom on 09Nov2021. Dr. (Name withheld) let dot and the pharmacist make the decision to give the second dose. They did not discuss with reporter and her mom how the decision was made before the shot (Second first) was given. No one appears to want to tell them what happened. They wish they would have contacted Pfizer, got recommend and discussed it with them. No one from Dr. (Name withheld) office checked on her mom to make sure she was feeling okay after the second first shot. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.