Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Vein disorder, Wrong technique in product usage process
Clinical narrative: off label use; booster; after the administration, they noticed that the vein was nicked.; after the administration, they noticed that the vein was nicked.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), 0.3 ml, single (Lot number: GH9694, Expiration Date: 15Nov2022) at the age of 73 years intramuscular, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ANTIBIOTIC EYE DROPS. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE, LOT: FC3182, NDC, EXP: Unknown), administration date: 28Aug2021, when the patient was 73-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, LOT: FP4554, NDC, EXP: Unknown), administration date: 13May2022, when the patient was 74-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Date: Unknown, NDC, LOT, EXP: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Date: Unknown, NDC, LOT, EXP: Unknown), for COVID-19 immunization. The following information was reported: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious), VEIN DISORDER (non-serious) all with onset 23Sep2022, outcome "unknown" and all described as "after the administration, they noticed that the vein was nicked."; IMMUNISATION (non-serious) with onset 23Sep2022, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious) with onset 23Sep2022, outcome "unknown".  Additional Information: It was reported that, the report was related to a study or program. Patient height and weight was unknown. Caller on behalf of a patient who received the Pfizer-BioNTech COVID-19 Vaccine, bivalent. The caller explained that, after the administration, they noticed that the vein was nicked. The caller wanted to know if there were any revaccination considerations for this case. The caller explained that they were sure they administered the full dose. Provided off-label disclaimers. However, the caller explained that the full dose was administered, she wanted to know if there were considerations for the specific case that she explained. Caller wanted to know if we had information on the antibody titers after vaccination with the bivalent booster. Reporter explained that we have information on studies that compared the bivalent vaccine and the original monovalent vaccine. Superiority of the anti-Omicron BA.1 NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine [Monovalent] was met. The reporter could not find information on the exact quantities, but the document may contain information of interest for this case. Other Conditions, Other Products and Investigations were unknown. Reported that when they administered the vaccine, they accidentally nicked the vein. Wanted to know what needed to, if anything. Clarified with the caller, the details provided by the transferring agent. Caller stated the vaccine was administered in the deltoid and did not know if it went through or what. It was raised afterwards, so she was assuming it was nicked. Nicked vein when administered vaccine was Friday night, 23Sep2022. The date provided was the 10-week expiration date since when they got it vaccine was out in the fridge. Patient did not receive first 2 doses at this location, caller did not have this information to provide. 3 weeks ago, a patient got antibiotic eye drops. Vaccination facility type not provided. Clarified that the patient received the vaccine at the same address as previously provided by the caller. No additional vaccines administered on same date of the Pfizer suspect. No AE(s) required a visit to emergency room and physician office.  No prior vaccinations (within 4 weeks). AE(s) following prior vaccinations was none, other than the typical Pfizer symptoms like, sore arm and feeling tired was no other reaction. Patients' medical history (including any illness at time of vaccination) was none. Family medical history relevant to AEs and relevant tests was none. NDC number of Bivalent Covid-19 vaccine was 59267030401.  Follow-up attempts are completed. No further information is expected.