Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Nausea, Poor quality product administered, Product preparation error
Clinical narrative: Nauseous; hot flashes/Usually has hot flashes but is having more sever hot; Headache; The vaccination provider mixed the Pfizer Covid Vaccine with bacteriostatic sodium chloride.; The vaccination provider mixed the Pfizer Covid Vaccine with bacteriostatic sodium chloride.; This is a spontaneous report from Pfizer sponsored program support via medical information team. A contactable pharmacist reporting same events under the same suspect product for 6 patients. This is for the third of 6 patients. A 55-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FF2587; Expiration Date: 31Dec2021) via intramuscularly, administered in arm left (reported as left arm) on 15Oct2021 (age at the time of vaccination was 55-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. Patient had no medical history and patient did not take any concomitant medications. Historical vaccine included, patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administered on 24Sep2021 as dose 1, single and received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administered on 15Oct2021 as dose 2, single both for COVID-19 immunization. Reporter stated his facility vaccinated 6 people from a vial of the Pfizer COVID vaccine with the sterile diluent and not the sodium chloride diluent on 15Oct2021. The reported wanted to know if these people need to come in and get re-vaccinated. Upon transfer, the reporter verified 6 patients received the vaccine mixed with sterile water diluent instead of sodium chloride. Caller was calling on behalf of his wife who received the second dose of the Pfizer Covid-19 vaccine on 15Oct2021 that was mixed with the wrong type of saline. It was mixed with bacteriostatic 0.9 percent Sodium Chloride instead of sterile normal saline. The headaches began on 15Oct2021 in the evening around 14:00. The headaches are ongoing and the caller was eating Advil like candy. Caller stated she does not have the Advil bottle with her at this time and was unable to provide NDC/lot/expiration. Caller does not have the Advil bottle with her currently and is unable to provide this information. DSU Agent asked dose and caller stated normal round caplet, 200. Caller stated the headaches are the same. Feeling nauseous began on Sunday, 17Oct2021 and the caller was still feeling nauseous just not as frequent. Usually had hot flashes but was having more sever hot flashes: Caller stated this was ongoing and the caller began to really notice this on 17Oct2021. The caller did not realize any part of this until received call on Tuesday, 26Oct2021. No additional vaccines administered on same date of the Pfizer. No AE(s) required a visit to emergency room or physician office. No prior vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. Relevant Tests: None. The clinical outcome of headache, hot flush, nauseous was not recovered.  Follow-up attempts are completed. No further information is expected.  Follow-up (29Oct2021): This is a follow-up report combining information from duplicate reports 202101483051 and 202101382748. The current and all subsequent information will be reported under manufacturer report number 202101382748. Added new events (headache, hot flush, nauseous), added start dates of suspect and additional information added.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101381408 same reporter/drug/event, different patient.;US-PFIZER INC-202101484913 same patient, different drug/event