Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: the vaccine had been left out too long; the vaccine had been left out too long; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 004F21A, Expiration Date: 17Jan2022) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing), notes: Stated that she had lupus prior to the vaccine and she was diagnosed with it 18 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Stated that she had the first shot 05Mar2021 with a lot number of EM9809.), administration date: 05Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Stated that she had the second shot 26Mar2021 with a lot number EN9208.), administration date: 26Mar2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 05Oct2021, outcome "recovered" (05Oct2021) and all described as "the vaccine had been left out too long"; PAIN IN EXTREMITY (non-serious) with onset 05Oct2021, outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Caller stated she received the pfizer covid 19 vaccine booster yesterday. Caller stated she got a call from the facility telling her the vaccine had been left out too long and to go back and get another shot. Caller stated she was told the molecules separated. Caller asked did that make it ineffective. Caller asked even it was left out too long she was thinking the benefits might still be effective. Caller asked if the molecules did not separate and make the vaccine ineffective and they put more in her, will it be too much for her system. Report is related to a study or programme. Patient is also the reporter. Patient stated that she took Pfizer Covid 19 as it was her booster shot, age bracket and immune compromised and it was time. No other products. Wanted to know if she got another shot that it will be too much medication on her that it will be harmful for her. Is for the Pfizer Covid 19 vaccine. Information confirmed as provided. Event details: Stated that she got the injection at 4:30 and started feeling sore arm at 10:00 when she went to bed. Treatment: Stated that she had been putting alcohol on it. Stated that was normal for her when she get injections. No further details provided. Stated that her blood tests show that it was under control. Stated that she was not on any medication. There is a product complaint.  Follow-up attempts are completed. No further information is expected.