Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: severe HA; body aches; fatigue; Administered one dose each of expired vaccine; Administered one dose each of expired vaccine; Patient administered another dose of the Pfizer COVID 19 Vaccine; Patient administered another dose of the Pfizer COVID 19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 68-year-old female patient received BNT162b2 (COMIRNATY), on 09Nov2021 at 08:18 as dose 3, (booster) 0.3 ml single (Lot number: FH8028, Expiration Date: 31May2022) at the age of 68 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "Fatigue" (ongoing); "Depression/Anxiety" (ongoing); "Depression/Anxiety" (ongoing); "Myalgia" (ongoing); "Cervical tension" (ongoing); "GERD" (ongoing); "Rhinitis" (ongoing); "Insomnia" (ongoing); "Obesity" (ongoing); "Osteoporosis" (ongoing); "Hypertension" (ongoing); "Hyperthyroidism" (ongoing). Concomitant medication(s) included: ALENDRONATE oral taken for osteoporosis (ongoing); FLUTICASONE PROPIONATE nasal taken for seasonal allergy (ongoing); ATORVASTATIN oral taken for blood cholesterol (ongoing); PREVACID oral taken for abdominal discomfort (ongoing); FLOVENT (ongoing); MONTELUKAST oral (ongoing); GABAPENTIN oral taken for back pain (ongoing); ZOLPIDEM oral taken for sleep disorder (ongoing); AMITRIPTYLINE oral taken for anxiety, sleep disorder (ongoing). Vaccination history included: BNT162b2 (1st dose, Lot: unknown; Expiration: unknown, Pfizer/BioNTech Covid-19 vaccine details, Dose: 1st, Date/time, Date: 16Apr2021, Site and route of injection, Route of administration: intramuscular [checked], Batch/lot number: other, please specify: given elsewhere), administration date: 16Apr2021, when the patient was 68-year-old, for Covid-19 immunization; BNT162b2 (2nd dose, Lot: unknown; Expiration: unknown, Pfizer/BioNTech Covid-19 vaccine details, Dose: 2nd, Date/time, Date: 05May2021, Site and route of injection, Route of administration: intramuscular [checked], Batch/lot number: other, please specify: given elsewhere), administration date: 05May2021, when the patient was 68-year-old, for Covid-19 immunization; flu shot, administration date: 06Jan2021, when the patient was 67-year-old, for Immunization; high dose fluzone (Lot: UJ760AC, Manufacturer: GSK, IM, Left Deltoid), administration date: 20Oct2021, when the patient was 68-year-old, for Immunization.  The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 09Nov2021, outcome "unknown" and all described as "Administered one dose each of expired vaccine"; OVERDOSE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 09Nov2021, outcome "unknown" and all described as "Patient administered another dose of the Pfizer COVID 19 Vaccine"; FACTOR VIII DEFICIENCY (non-serious), outcome "recovered", described as "severe HA"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered". Therapeutic measures were taken as a result of factor viii deficiency, pain, fatigue.  Additional information: Prior vaccination (within 4 weeks) was Flu zone. Specific relevant test for thromboembolic event with thrombocytopenia were None. Patient in to office to receive 3rd covid-19 vaccine and medical assistant did not notice that the Pfizer in fridge were from the night before (08Nov2021). MA gave vaccine to patient at 08:18 and then went to chart vaccine she noticed time on syringe was from previous afternoon. Call was made to immune coordinator, she was advised to give another Pfizer vaccine that was drawn on 09Nov2021. 2nd Pfizer covid-19 given at 08:40. Call made to risk manager at that time. Pfizer immediately called informed AE, no need for 2nd Pfizer. Pt notified Pt 40 severe HA, body aches, fatigue after 2 Pfizer covid vaccines was treated with OTC Ibuprofen + Tylenol. No further complaints from pt. made complete recovery. There were no relevant tests.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Recoded the event verbatim "Administered one dose each of expired vaccine" from "Expired vaccine used" to "Product administration error", and coded the new event verbatim "Administered one dose each of expired vaccine" coded as "Poor quality vaccine administered" and event verbatim "Patient administered another dose of the Pfizer COVID 19 Vaccine" coded as "Inappropriate dose of Vaccine administered".  Follow-Up (25Mar2022): Follow-up attempts are completed. No further information is expected.  Follow-up (12Apr2022): This is a spontaneous follow-up report received from a contactable Nurse. This Nurse reported in response to HCP letter sent which included that: Updated information included Primary reporter's middle name, Suffix and Alternate Phone, new AE: "Hemophilia A, Ache, Fatigue", dose 1, 2 details, concomitant drug, 3rd dose details, relevant medical history.  Follow-up (15Apr2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101549752 Same reporter drug AE, different patient