Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product temperature excursion issue
Clinical narrative: more about 14 to 16 hours at room temperature and was administered to the patient/received their dose of the Covid Vaccine after the 6 hours had been lapsed; more about 14 to 16 hours at room temperature and was administered to the patient; received their dose of the Covid Vaccine after the 6 hours had been lapsed; This is a spontaneous report from a contactable Nurse. A 40-year-old patient female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Vaccine Lot Number: ER8735, Expiry Date of Covid Vaccine: Jul2021), at the age of 40-year-old via an unspecified route of administration on 03Jun2021  08: 30 in Arm Left at an 1st dose, 0.3Ml single dose for COVID-19 immunization. The patient's medical history was none. Concomitant medications were not reported. It was reported that nurse wanted to know the risks associated for administering the Pfizer BioNTech Covid-19 vaccine 14 to 16 hours after dilution. Nurse stated that the diluted vaccines were left in the syringes at room temperature for more about 14 to 16 hours at room temperature and was administered to the patient. Upon follow up on 03Jun2021, the patient received their dose of the Covid Vaccine after the 6 hours had been lapsed from 03Jun2021 08:30. Reporter seriousness for received their dose of the Covid Vaccine after the 6 hours had been lapsed was Medically significant. Reporter seriousness for "patient was supposed to receive Moderna today. Pfizer clinic was held yesterday and the Moderna clinic was today, but they patient received a dose of the Pfizer vaccine today." was not serious. Event relatedness: Covid Vaccine: received their dose of the Covid Vaccine after the 6 hours had been lapsed - Unknown. Covid Vaccine: patient was supposed to receive Moderna today. Pfizer clinic was held yesterday and the Moderna clinic was today, but they patient received a dose of the Pfizer vaccine today. - Unknown. Nurse states this was the patient's first dose. Nurse states the patient was supposed to receive Moderna today. Nurse states they had a Pfizer clinic yesterday and the Moderna clinic was today, but they patient received a dose of the Pfizer vaccine (from 03Jun2021 08:30).  Treatment: None, not noted until after her 15 minutes, no side effects. Seriousness Criteria: Caller states she would say it is Medically Significant to notify the patient and Pfizer, because there is not 100% known about receiving a vaccine that is considered expired. Vaccination Facility Type was Physician Office. History of all previous immunization with the Pfizer vaccine considered as suspect was none.  Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant tests was none. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (03Jun2021): New information received from a contactable Nurse includes: the patient's gender, new events (patient was supposed to receive Moderna today. Pfizer clinic was held yesterday and the Moderna clinic was today, but they patient received a dose of the Pfizer vaccine today. received their dose of the Covid Vaccine after the 6 hours had been lapsed) added.   Follow up needed, further information has been requested.