Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Poor quality product administered, Product temperature excursion issue, Vaccination site pain
Clinical narrative: Pt said that he had normal side effects of headache, diarrhea+sore arm after the injection; Pt said that he had normal side effects of headache, diarrhea+sore arm after the injection; Pt said that he had normal side effects of headache, diarrhea+sore arm after the injection; Was diluted on 22Oct2021 and stored in the refrigerator in the vial for at least 72 hours before it was administered as a booster dose; Was diluted on 22Oct2021 and stored in the refrigerator in the vial for at least 72 hours before it was administered as a booster dose; Caller relays the patient had Johnson & Johnson Covid vaccine on 12Jul2021; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 44 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 25Oct2021 15:30 (Lot number: EW0179, Expiration Date: Nov2021) at the age of 44 years as dose 2 (booster), single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE), administration date 12Jul2021 (Lot number: 206A21A, Expiration Date: 07Aug2021) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 25Oct2021 15:30, outcome "unknown" and all described as "Was diluted on 22Oct2021 and stored in the refrigerator in the vial for at least 72 hours before it was administered as a booster dose"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 12Jul2021, outcome "unknown", described as "Caller relays the patient had Johnson & Johnson Covid vaccine on 12Jul2021"; HEADACHE (non-serious), DIARRHOEA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "Pt said that he had normal side effects of headache, diarrhea+sore arm after the injection". The action taken for janssen covid-19 vaccine was unknown.  Additional information: HCP was calling about the Pfizer Covid-19 vaccine that was diluted on 22Oct2021 and stored in the refrigerator in the vial for at least 72 hours before it was administered as a booster dose to a 44 year-old male who had previously received the Johnson & Johnson Covid-19 vaccine as a primary vaccination. HCP was asking if there was any recommendations for the above temperature and handling excursion of the above administration of the Pfizer Covid-19 vaccine booster dose. NDC number of Covid BioNTech vaccine booster: 59267-1000-01. Caller stated seriousness criteria was hard to say, that's why she was calling. Caller relays the patient had Johnson & Johnson Covid vaccine on 12Jul2021. NDC 59676-580-05, lot 206A21A, expiry 07Aug2021. Caller relays it was stored in the refrigerator. Vaccination facility type: Doctors office/urgent care. Prior vaccination (within 4 weeks) was reported None. Relevant tests: Unknown. Specific relevant test for thromboembolic events with thrombocytopenia: Unknown. Questionaries included: Please clarify the type of medication error - Pfizer vaccine given, after patient left it was found that it was an expired bottle from the Friday before; Please provide the stage of medication error (e.g. prescribing, dispensing, preparation and administration) - Expired vaccine; Please provide contributing factors to the medication error - Vaccine was not wasted on Friday. MA did not check the date correctly on Monday before drawing the vaccine; Please clarify if the medication error affected the patient or consumer with clinical consequences.  No follow-up attempts are possible. No further information is expected.