Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: Fatigue; arm was extremely sore; inadvertently administered doses that were undiluted; inadvertently administered doses that were undiluted; This is a spontaneous report received from contactable reporter (Other HCP) from medical information team.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:15 (Lot number: FF2587, Expiration Date: 20Dec2021) at the age of 51 years as dose number unknown, 0.4 ml single for COVID-19 immunisation. Relevant medical history included: "CLL" (unspecified if ongoing); "Celiac" (unspecified if ongoing); "Crohn's" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ERROR (medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "inadvertently administered doses that were undiluted"; FATIGUE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Fatigue"; PAIN IN EXTREMITY (medically significant) with onset 19Nov2021, outcome "unknown", described as "arm was extremely sore". Clinical course: Nurse stated that they administered several doses of the purple cap Covid 19 vaccine yesterday, but they had a staff member that assisted and inadvertently administered doses that were not diluted to 5 different patients. 4 patients were female, and 1 was male. The male patient was born in (year withheld). 2 of the female patients were born in (year withheld), 1 of the female patients was born in (year withheld), and the other female patient was born in (year withheld). Three patients were given the dose as the 1st dose, 1 was a booster dose, and 1 was a 2nd dose. This patient received an undiluted dose of the vaccine yesterday at 11:20am. Caller states that she has talked to the patient twice today. This morning the patient said that she was extremely tired, her arm is killing her, and she gets dizzy when she raises up. The patient didn't want to be seen by anybody and just wanted to rest. The patient stated that she feels like she did when she had Covid in Aug2021. She told the nurse that she woke up with these symptoms at 5am this morning. When the caller talked with her this afternoon, the patient stated that her head wasn't hurting quite as bad. The events did not require emergency Room visit and physician Office visit. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No Family Medical History Relevant to AEs.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of fatigue,pain in extremity,product preparation error,overdose. 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) : US-PFIZER INC-202101626100 same reporter/drug, similar event, different patient