Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose, Pain in extremity, Product preparation issue, Product use issue
Clinical narrative: The product was diluted with only 0.18mL of saline instead of 1.8mL of saline as instructed.; Product preparation issue; The patient wants to know if she should stop breastfeeding. / caller says she is going to assume the baby has been exposed.; The patient wants to know if she should stop breastfeeding. / caller says she is going to assume the baby has been exposed.; she only had a sore arm; This is a spontaneous report from a contactable pharmacist for both mother and fetus/baby. This is the maternal report.  A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17May2021 (Batch/Lot Number: EW0172; Expiration Date: Aug2021) as 0.3 mL, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller states that she reconstituted a vial of Pfizer COVID-19 vaccine this morning and she thought that she was using a 10mL syringe to dilute with 0.9% Sodium Chloride, however, she realized that she had used a 1 mL syringe which meant that the vial had only been diluted with 0.18 mL of 0.9% Sodium Chloride. The caller states that this was administered to one patient who is a 39 year old breast feeding female. They monitored the patient for 15 minutes after the injection, which was given at 9:00 AM this morning. They called her at 2:00 PM this afternoon to notify her of the mistake and check on her to which the patient reported that she only had a sore arm. The patient is unsure if she had breastfed her baby after receiving the dose or not at that point. Caller states she is a pharmacist at withheld. States she is calling to report a medication error when administering the vaccine. States when she mixed the vaccine in the vial with the saline, she thought she was using a 10ml syringe but was using a 1mL syringe. States the product was diluted with only 0.18mL of saline instead of 1.8mL of saline as instructed. Caller states she did administer 0.3ml to a patient from the vial that was not diluted properly. States the patient has experienced no adverse events. Wants to know what they need to do if they need to do anything. Patient received the dose this morning, 17 May2021 at around 9AM-9:15AM. Caller states that the patient is also breastfeeding, the caller states the patient wants to know if she should stop breastfeeding. Caller states she has no patient information for the baby, states knows the baby is likely under 6 months only because she saw the baby this morning and it was tiny. Caller states she is unsure if the baby has been exposed through breastmilk, states the patient said she fed the baby a bottle but was unsure if it was pumped breastmilk from today after the vaccine or from before the vaccine, caller says she is going to assume the baby has been exposed. Outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021559108 same drug/reporter, different AE/baby case;US-PFIZER INC-2021559108 same drug/reporter, different AE/mother case