Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality product administered, Product storage error
Clinical narrative: Sore arm; stored the vial at room temperature for an extended amount of time with no protection from room light; stored the vial at room temperature for an extended amount of time with no protection from room light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 11:50 as dose 4 (booster), 0.3 ml single (Lot number: GJ6739, Expiration Date: Dec2022) at the age of 36 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER, the original dose formulation), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER, the original dose formulation), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Oct2022, outcome "not recovered", described as "Sore arm"; PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 06Oct2022, outcome "unknown" and all described as "stored the vial at room temperature for an extended amount of time with no protection from room light". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The reporting consumer was the patient. Patient stated she was given the Pfizer-Biontech Covid bivalent vaccine today as booster (her first and only dose of the Pfizer Covid Bivalent Booster). She called because she is concerned about how the Pharmacist handled the storage of the product today that she was administered. She noticed that they stored the vial at room temperature for an extended amount of time with no protection from room light. She saw the Pharmacist drawing the Pfizer Covid Bivalent Booster using a syringe from a bottle; they put the vial in the orange bottle (like that usually hold prescription pills) with no cap and left it on a bench where she administers vaccines to people; at room temperature. Patient added that she is aware that "usually vaccines are covered." Patient said she does not know how long the Pfizer-Biontech Covid bivalent vaccine vial was at room temperature but she was at pharmacy at 11:00 and she got the dose at 11:50. She added she saw the pharmacist prepare the vaccine, "where she took it from the table." When she asked the pharmacist if the vial can be stored at room temperature, she was told yes. She mentioned she "searched online, I didn't realize they should cover the vial." Patient asked if the dose was viable, if the product is still good. She also mentioned towards the end of this report that she just started feeling a little bit of a sore arm so she might have some side effects the next day. She has not had any treatments or medical interventions relative to these events to report. She mentioned that prior to this product she had 2 of the original dose formulation and a booster but provided no further details on those products.  Follow-up attempts are completed. No further information is expected.