Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: extremely tired; her arm is killing her; she gets dizzy when she raises up; Head is hurting; 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 19 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:20 (Lot number: FF2587, Expiration Date: 20Dec2021) as dose number unknown, 0.4 ml single for COVID-19 immunisation. Relevant medical history included: "COVID-19", start date: 21Aug2021 (unspecified if ongoing), notes: Verbatim: COVID-19. The patient's concomitant medications were not reported. 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 "extremely tired"; LIMB DISCOMFORT (medically significant) with onset 19Nov2021, outcome "unknown", described as "her arm is killing her"; DIZZINESS (medically significant) with onset 19Nov2021, outcome "unknown", described as "she gets dizzy when she raises up"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Head is hurting". 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.; Sender's Comments: Based on known drug safety profile, there is no reasonable possibility of causal association between the events Overdose, Product preparation error, Fatigue, Limb discomfort, Dizziness, and Headache and BNT162B2.  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-202101630079 same reporter/drug, similar event, different patient;US-PFIZER INC-202101630078 same reporter/drug, similar event, different patient;US-PFIZER INC-202101630076 same reporter/drug, similar event, different patient;US-PFIZER INC-202101630077 same reporter/drug, similar event, different patient