Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose, Pain in extremity, Poor quality product administered, Vaccination site pain
Clinical narrative: the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used/ Caller mentioned that one dose of that reconstituted vaccine was given to a female patient; intense arm pain; injection site pain; This is a spontaneous report from a contactable other health care professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/ lot number was not reported) via an unspecified route of administration on an unspecified date, as a DOSE 1,SINGLE (at the age of 62-year-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the caller mentioned that they have been holding campaigns at their clinic and one of the clinic nurses brought to his attention that 3 doses were drawn out of one vial of the Pfizer BioNTech COVID-19 vaccine. Caller mentioned that the nurses are reconstituting their own vaccines and has not determined if wrong amount of diluent was used. Caller mentioned that one dose of that reconstituted vaccine was given to a female patient. Confirmed that 0.3ml of 3 doses, equivalent to 0.9ml was drawn out of that vial of the vaccine. Caller wanted to know what the adverse reactions are for being given an overdose of the Pfizer BioNTech COVID-19 vaccine. Caller also asked if it was the patients first dose, if that would change anything on the recommendations. On 12Aug2021, stated that he spoke to a representative who said do not repeat the dose, and he asked for clarification on that as to whether or not to give the second dose, as this was the patient's first dose. Caller also mentioned that more intense arm pain/injection site pain for the patient was something he should watch for. The outcome of the events were unknown.   Information on lot number/batch number has been requested. The lot/batch number is not available despite the follow-up attempts made.   Follow up (12Aug2021): This is a spontaneous report from a contactable other health care professional. New information include, caller also mentioned that more intense arm pain/injection site pain for the patient was something he should watch for.    Information on the lot/batch number has been requested.  Follow-up (30Aug2021)This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Updated information: At risk classification removed, age at vaccination added.  Follow-up attempts completed. No further information is expected.