Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product preparation error
Clinical narrative: body aches; Chills; Headache; sore arm; Booster shot; booster shot was mixed with sterile water instead of normal saline; booster shot was mixed with sterile water instead of normal saline:The caller was really surprised to be called yesterday and told that the vaccine wasn't active; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 43-year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 19Nov2021 (Lot number: FH8028) at the age of 43 years as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: she actually had COVID before and this day was worse than COVID. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Vaccine Name: First dose of the Pfizer COVID-19 vaccine , Lot Number / Expiry Date: EL0142/ unknown, She has a sticker on her vaccine record card and it only has the Lot number and where it was given , Route, Anatomical Location:Unknown, she believes the first dose was in her left deltoid), administration date: 12Jan2021, when the patient was 43 years old, for COVID-19 Immunization; Bnt162b2 (Dose:2, Vaccine Name: Second dose of the Pfizer COVID-19 Vaccine, Lot Number / Expiry Date: EL9264/ unknown , Route, Anatomical Location: Unknown, she believes it was in her right deltoid), administration date: 03Feb2021, when the patient was 43 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster shot"; PRODUCT PREPARATION ERROR (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster shot was mixed with sterile water instead of normal saline/they mistakenly used sterile water for injection instead of sterile sodium chloride as the diluent and that she needs to get the shot again."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster shot was mixed with sterile water instead of normal saline: The caller was really surprised to be called yesterday and told that the vaccine wasn't active"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "body aches"; CHILLS (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Chills"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "sore arm".  Additional information: NDC number of Pfizer COVID-19 vaccine was reported as Unknown, Expiry Date of Pfizer COVID-19 vaccine was reported as Unknown. Other Products was reported as No, Patient History was reported as No, Investigation Assessment was reported as No. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The caller clarified she had her booster shot done at withheld last Friday, 19Nov2021. She got a call that day that it was mixed with sterile water, and it needed to be mixed with normal saline. She guessed the diluents activates the ingredients. However, she did had side effects after the shot, so she was worried about going and doing that again, but she wanted to be protected.She confirmed that she had the following side effects: body aches, chills, headache, sore arm. She confirmed she only had these side effects just on Saturday, 20Nov2021. She recovered completely from them. This was her third shot. She mentioned she actually had COVID before and this day was worse than COVID. The caller was really surprised to be called yesterday and told that the vaccine was not active, and she would need to go and do it again.  Follow-up attempts are completed. No further information is expected.