Age: 83.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Expired product administered, Immunisation
Clinical narrative: Left foot swelling; Aches and pains in lower back and legs; Aches and pains in lower back and legs; Aches and pains in lower back and legs; Given dose of vaccine that had sat out for 30 minutes too long; nurses gave her mom an expired vaccine on Thursday; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101705993 (Pfizer).  A 83 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Nov2021 15:00 (Batch/Lot number: unknown) at the age of 83 years as dose 1, single and administered in arm right, administration date 09Nov2021 14:00 (Lot number: LiFG3527, Expiration Date: Feb2022) 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: 31Aug2021, stop date: 10Nov2021, notes: Verbatim: Hip surgery; "Low iron levels", start date: Feb2021 (ongoing), notes: has has a colonoscopy and an endoscopy; "Hip pain", start date: Nov2020 (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 surgeryNurse practioner gave her cream to put on her joints; "leg pain following the first covid-19 vaccine", start date: 05Nov2021, stop date: 08Nov2021, notes: legs hurt after the first vaccination. She did not want to see a doctor. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); GLIPIZIDE taken for diabetes mellitus (ongoing); PROZAC taken for depression (ongoing); CALCIUM (ongoing); LISINOPRIL. Vaccination history included: Flu shot (Anatomical site of injection: Left arm), administration date: 13Oct2021, for immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 04Nov2021, outcome "unknown", described as "Given dose of vaccine that had sat out for 30 minutes too long"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 04Nov2021, outcome "unknown", described as "nurses gave her mom an expired vaccine on Thursday"; BACK PAIN (non-serious), PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset 05Nov2021, outcome "recovered" (07Nov2021) and all described as "Aches and pains in lower back and legs"; PERIPHERAL SWELLING (non-serious) with onset 12Nov2021, outcome "unknown", described as "Left foot swelling". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: This consumer (patient's daughter) reported for an 83-year-old female patient (reporter's mother). Reporter stated that she is calling about the Pfizer Product: Covid 19 Vaccine. Stated that her problem is different than most. Her mom had gotten the vaccine last Thursday and then she was improperly given another dose on Tuesday. Reporter stated 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. Reporter stated that one of the nurses gave her mom an expired vaccine on Thursday. That nurse then called the caller's mom and made it sound urgent and said the doctor had given permission for the shot to be re-administered on Tuesday. Reporter stated that the nurse only talked to a pharmacist that is part of the local hospital system. Suspect Products: Reporter stated that her mom has the card with the information from the shot she received on Tuesday, 09Nov2021. Reporter does not have the NDC, Lot Number, or Expiry date for this vaccine. Reporter stated that the nurse shredded the card for the vaccine her mother was given on Thursday, 04Nov2021. Reporter does not have the NDC, Lot Number, or Expiry date for that vaccine either. Reporter stated that the vaccine her mother was given on Thursday 04Nov2021 was her mother's first dose of the Pfizer Covid Vaccine. 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 stated that her mom likes her doctor and always wants to do as he says. Reporter also stated that 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. History: Reporter stated that her mother had hip surgery at the end of Oct, then corrects and says it was the end of Aug2021. Reporter stated her mother has been recovering from that well. She was healing nicely and was not having any pain. Reporter stated that her mother and sister then told the caller that the Friday, Saturday, and Sunday after the vaccine received on 04Nov2021, her mother had some aches and pains in her lower back and legs. Later in the call the reporter mentions that her mother takes medication for diabetes and high blood pressure. Stated that has been ongoing for a long time. Also says her mother is weaning off of an unspecified pain medication since the hip surgery. Reporter stated that her mother received a flu vaccine from withheld, she thinks it was on 18Oct2021. Reporter does not know the NDC, Lot Number, or Expiry Date for this flu vaccine. Patient is scheduled to receive a third dose on 06Dec2021 . We want to know if she needs it and if yes, should it be a smaller dose. After surgery, (Name withheld) did physical therapy with a therapist that came to her home. (Name withheld) 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 AdIline. After the shot on 04Nov2021, (Name withheld) had severe leg pains for three days. She rested and did not want to see a doctor. (Name withheld) had severe leg pains again on 11Nov2021 and her left foot swelled. An ultrasound done 12Nov2021 showed no blood clots. She is still experiencing leg pain. The left one hurts the worse. Comments/Narrative: (Name withheld) was given a first Pfizer vaccination on 04Nov2021. The medical assistant (Name withheld) who gave her the first shot called my mom on 09Nov2021. She told my 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 I asked her if my mom should get another first vaccination so close to the other one, she said Dr. (Name withheld) was on top of it. She said my mom shouldn't have any side effects. We never saw a doctor and no one told us how it was determined that my mom needed another shot. We were given vague answers. Before (Name withheld) gave mom the second first shot, she said that it had been out 10 minutes too long. We 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 my mom before it was given. We also wanted to know now much she was given on 04Nov2021 and 09Nov2021. We 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. From what we have been told on 09Nov2021 and later, someone told (Name withheld), I hope you did not use that. She told dot about it. Dr. (Name withheld) let dot and the pharmacist make the decision to give the second dose. They did not discuss with us how the decision was made before the shot (Second first) was given. No one appears to want to tell us what happened. We wish they would have contacted Pfizer, got your recommend and discussed it with us. No one from Dr. (Name withheld) office checked on my mom to make sure she was feeling okay after the second first shot.  The lot number for bnt162b2 was not provided and will be requested during follow up.