Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Overdose, Product preparation error
Clinical narrative: arm was extremely sore; inadvertently administered doses that were undiluted / Received dose that was not diluted; inadvertently administered doses that were undiluted / Received dose that was not diluted; Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster; Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster; Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster.; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [19Nov2021], this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 40 year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), administered in arm right, administration date 18Nov2021 11:30 (Lot number: FF2587, Expiration Date: 20Dec2021) at the age of 40 years as dose 3 (booster) 0.4 ml, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Family Medical History Relevant to AE was None. Relevant Tests was None. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). Vaccination history included: Moderna covid vaccine (Moderna Covid Vaccine, 1st dose: 08Jan2021, Lot: 039K20A, Expiry: 29Jan2021), administration date: 08Jan2021, when the patient was 40 years old, for COVID-19 immunization; Moderna covid vaccine (Moderna Covid Vaccine, 2nd dose: 05Feb2021, Lot: 007M20A, Expiry: 06Mar2021), administration date: 05Feb2021, when the patient was 40 years old, for COVID-19 immunization; Flu shot (Flu shot on 29Sep2022, Manufacturer: Seqires, Lot: Z3MK7, Expiry: 30Jun2022.), administration date: 29Sep2021, when the patient was 40 years old, for Immunization. Events following prior vaccinations were None. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 18Nov2021 11:30 and all described as "inadvertently administered doses that were undiluted / Received dose that was not diluted"; VACCINATION SITE PAIN (medically significant) with onset 19Nov2021, described as "arm was extremely sore"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 18Nov2021 11:30 and all described as "Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster"; IMMUNISATION (non-serious) with onset 18Nov2021 11:30, described as "Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster.". Clinical course: Nurse said they administered several doses of the purple cap presentation of the Pfizer-BioNTech Covid-19 Vaccine on 18Nov2021. HCP said they had a float staff member that assisted and inadvertently administered doses that were undiluted. She said it was administered to 5 different patients. 4 were female and 1 was male. She said 3 were given as the 1st dose, 1 as the booster dose, and 1 as the 2nd dose. This report is for one of the female patients. Patient received the Moderna Covid Vaccine for her first 2 doses and chose to receive the Pfizer Covid Vaccine for her booster. Reporter seriousness for received dose that was not diluted was medically significant. On 19Nov2021, patient experienced arm was extremely sore. The event did not require a visit to Emergency Room nor the Physician Office.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events Headache cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202101626100 same reporter/drug, similar event, different patient