Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Fatigue; Diarrhea; Myalgia; the vials would expire on 28Jul2021 at 6:00pm. It was opened 28Jul2021 around 12nn. On 30Jul2021 the vaccines was administered; the vials would expire on 28Jul2021 at 6:00pm. It was opened 28Jul2021 around 12nn. On 30Jul2021 the vaccines was administered; This is a spontaneous report from a Pfizer-sponsored program Support via medical information team. A contactable other healthcare professional (medical assistant) reported for a 61-year-old female patient that: A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via intramuscular route of administration in right deltoid on 30Jul2021 at 12:03 (at the age of 61-year-old, Batch/Lot Number: EW0177; Expiration Date: Aug2021) as dose 1, single for COVID-19 immunisation at family medicine clinic. Relevant medical history included Asthma, Diabetes, High cholesterol, Fibromyalgia, High blood pressure, Obesity and Sleep apnea all these unspecified if ongoing. Concomitant medication(s) included Symbicort, Carvedilol, Duloxetine, Tresiba, Victoza, Metformin, Omeprazole, Pioglitazone, Pramipexole, Lyrica, Crestor and Tamsulosin. Caller stated that they have vaccines that on the printed label will expire as per manufacturer was Aug2021. Also, there was sticker that was placed (caller was not the one who placed the note) that the vials would expire on 28Jul2021 at 6:00pm. On 30Jul2021 12:03 patient experienced the vials would expire on 28Jul2021 at 6:00pm. It was opened 28Jul2021 around 12nn. On 30Jul2021 the vaccine was administered. On unspecified date patient experienced Fatigue, Diarrhea and Myalgia. When reporter confirmed to get more information to check Pfizer's stability data, Caller does not have yet a specific time and temperature that their vaccines has reached. Asked to check just to be sure their vaccine was really expired. On 30Jun2021, three doses of the Pfizer COVID 19 Vaccine were administered and after realized the Pfizer COVID 19 Vaccine was dated 28Jun2021 and had expired. The caller has questions pertaining to this event. Caller clarifies date the Pfizer COVID 19 Vaccines were administered was 30Jul2021 and the expired date was 28Jul2021. The caller stated she needs to check with her supervisor and make sure it was okay to provide the patient's information. The caller stated that was why she was contacting Pfizer; caller was sure it was not life threatening but this was the reason contacting Pfizer. The case was reported as non-serious. The patient was provide information regarding the reported adverse event(s) with the use of the product. The Pfizer product had a causal effect to the adverse event. Vaccination facility type was doctor's office/urgent care. Vaccine was not administered at military facility. No any prior vaccinations (within 4 weeks). No any relevant tests. 1st Dose of Covid vaccine given >24 hours after vial had been opened was kept refrigerated in vial. Vial should have been thrown out day before. Patient was not received treatment for fatigue, diarrhea and myalgia. The outcome of event's Fatigue, Diarrhea and Myalgia were recovered on date 06Aug2021 and outcome of other event's were Unknown.  Follow-up (13Sep2021): Follow-up attempts completed. No further information expected.  Follow-Up (17Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (20Sep2021): This is a follow up spontaneous report from a contactable Physician. This Physician reported in response to the HCP letter sent that included route of administration, medical history, Concomitant medication and event Fatigue, Diarrhea and Myalgias and other relevant information was added.   Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.  Follow-up (04Oct2021): This is a follow up spontaneous report from a contactable Physician. This Physician reported in response to the HCP letter sent that included No medically relevant and new information was added.  Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s) : -PFIZER INC-202100986879 same reporter/SD/AE, different patient;-PFIZER INC-202100986878 same reporter/SD/AE, different patient