Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Product storage error
Clinical narrative: Received vaccine exposed to temperature excursion; Received vaccine exposed to temperature excursion; Difficulty lifting arm; May have been a patient who received the vaccine beyond the end of the workday; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), received from a contactable nurse. A 55-year-old male patient received pneumococcal 13- valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), intramuscular in the left deltoid on 16Jul2019 08:30 at 0.5 ml, single for immunization. Medical history included ongoing hypertension, substance abuse, arthralgia, hyperlipidemia and tobacco use. Concomitant medication included atorvastatin calcium (LIPITOR) for hyperlipidaemia, losartan potassium (COZAAR) for hypertension and ranitidine hydrochloride (ZANTAC); all ongoing. Concomitant vaccines includes hepatitis a vaccine (HEPATITIS A; lot number: N39BM, expiry date: 31Jan2022) intramuscular in the right deltoid, diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP; lot number: X5R7Y, expiry date: 14Nov2020) intramuscular in the left deltoid and hepatitis b vaccine (lot number: L9539, expiry date: 07Dec2021) intramuscular in the right deltoid; all administered on 16Jul2019 for immunization. On 16Jul2019, the patient received the vaccine exposed to temperature excursion on unspecified date. The vaccine was labeled with 'do not use' however was still given to the patient. Information on the batch number has been requested.  Follow-up (23Aug2019): This follow-up is being submitted to notify that the batch number is not available despite the followup attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (05Sep2019): This is a follow-up report combining information from duplicate reports 2019306934 and 2019310592. The current and all subsequent information will be reported under manufacturer report number 2019310592. This is a spontaneous report from a contactable other health professional. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The caller reported that once the sterile seal had been broken, the vaccine should be used or discarded at the end of the workday. Caller stated there might have been a patient who received the vaccine beyond the end of the workday.  Follow-up (23Aug2019): This follow-up is being submitted to notify that the batch number is not available despite the followup attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (05Sep2019): New information reported from a contactable Nurse included: Incorrect info given to reporter. There was not a temp excursionit was given the day after it was 'drawn up'. (as reported). Suspect pneumococcal 13- valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) Batch/Lot # X62324 was administered by a Physician. Concomitant vaccines: 1st dose of hepatitis a vaccine (HAVRIX Hep A, Glaxo Smith Kline), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (BOOSTRIX Tdap, Glaxo Smith Kline, Lot # 2Y74B, Expiry Date 11Oct2020) IM at left deltoid, 1st dose of hepatitis b vaccine (ENERGIX Hep B, Glaxo Smith Kline). Vaccine single dose syringe has needle applied to syringe during clinic the day i.e. 15Jul2019 before and should have been wasted, however a staff member used it anyway on 16Jul2019. The patient experienced difficulty lifting arm on 16Jul2019 3:00pm, not requiring hospital admission.