Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered doses that were undiluted; inadvertently administered doses that were undiluted; Severe headache and couldn't lift his head off the bed; Chest was uncomfortable; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 23-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 11:00  (Lot number: FF2587, Expiration Date: 20Dec2021) at the age of 23 years as dose number unknown, 0.4 ml single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing); "Nicotine dependence" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (hospitalization, medically significant), OVERDOSE (hospitalization, medically significant) all with onset 18Nov2021, outcome "unknown" and all described as "inadvertently administered doses that were undiluted"; HEADACHE (hospitalization, medically significant) with onset 18Nov2021, outcome "unknown", described as "Severe headache and couldn't lift his head off the bed"; CHEST DISCOMFORT (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Chest was uncomfortable". The patient was hospitalized for product preparation error, overdose, headache (start date: 18Nov2021, discharge date: 19Nov2021, hospitalization duration: 1 day(s)). The events "inadvertently administered doses that were undiluted", "inadvertently administered doses that were undiluted", "severe headache and couldn't lift his head off the bed" and "chest was uncomfortable" were evaluated at the emergency room visit. Clinical course was reported as follows. The 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. HCP wants to know if the patients need to be revaccinated. This patient received an undiluted dose of the vaccine yesterday at 11am. The reporter stated the patient called her last night and said that he was experiencing a severe headache and couldn't lift his head off the bed and his chest was uncomfortable. He said he started noticing the symptoms about 30 minutes prior to calling her. Caller states that she sent him to the ER at when he called her; he arrived in the ER. By the time he got to the ER the chest discomfort was gone. The hospital admitted him overnight for observation. The patient left on 19Nov2021 at 11:05 in the morning. The patient was very dramatic in the ER. Lab work and chest x-ray were completed while he was in the hospital with no acute findings. An ECHO was ordered, but he left the hospital before it was done.; Sender's Comments: Based on the available reported information, the causal association between the events product preparation error, overdose and headache and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. ,Linked Report(s) : US-PFIZER INC-202101626100 same reporter/drug/event, different patient