Age: 67.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Poor quality product administered, Product administration error, Product use issue, Respiratory rate
Clinical narrative: coronary artery bypass graft; A multi-dose vial of this vaccine was opened (punctured) yesterday at 2:30 PM and a dose was administered today at 8:44 AM; A multi-dose vial of this vaccine was opened (punctured) yesterday at 2:30 PM and a dose was administered today at 8:44 AM; Pneumococcal (Pneumovax 23) 14Dec2022; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Dec2022 at 11:09 as dose 5 (booster), single (Lot number: GJ3274, Expiration Date: 07Feb2023) at the age of 67 years intramuscular, in right deltoid for COVID-19 immunisation; pneumococcal vaccine (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE]), on 14Dec2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Smoking Never" (unspecified if ongoing), notes: Smoking Never , Smokeless Tobacco Never , Vaping Never used; "Alcohol No" (unspecified if ongoing); "Breast cancer" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Laparoscopic ovarian cystectomy" (unspecified if ongoing), notes: laparoscopic ovarian cystectomyX2; "Knee surgery" (unspecified if ongoing); "mastectomy right" (unspecified if ongoing); "Breast reconstruction right" (unspecified if ongoing); "Essential hypertension" (unspecified if ongoing); "Hyperlipidaemia" (unspecified if ongoing); "Precordial pain" (unspecified if ongoing); "Dyspnea on exertion" (unspecified if ongoing); "Coronary artery disease" (unspecified if ongoing); "Hx of CABG" (unspecified if ongoing); "neuropathy" (unspecified if ongoing); "Skin eruption" (unspecified if ongoing); "Physical deconditioning" (unspecified if ongoing); "Bone disorder" (unspecified if ongoing); "Current tear of medial cartilage or meniscus of knee" (unspecified if ongoing); "Knee pain" (unspecified if ongoing); "Pain in limb" (unspecified if ongoing); "Sprain of ankle" (unspecified if ongoing). Concomitant medications included: ASPIRIN 81 chewable tablet; EXEMESTANE 25 mg tablet; ZETIA 10 mg tablet; FLUOCINOLONE ACETONIDE ACETATE 0.01 %; HYDRODIURIL 25 MG tablet; HYDROCORTISONE 2.5 % cream; LOPRESSOR 100 MG tablet; NITROSTAT sublingual 0.4 MG SL tablet; CRESTOR 40 MG tablet; KENALOG [TRIAMCINOLONE ACETONIDE] 0.1 % cream; CALCIUM CARBONATE;COLECALCIFEROL;MINERALS NOS 600-400 MG-UNIT Tab. Past drug history included: Clotrimazole, reaction: "Rash". Vaccination history included: moderna (Dose: 01), administration date: 11Feb2021, when the patient was 65-year-old, for COVID-19 immunization; moderna (Dose: 02), administration date: 23Mar2021, when the patient was 65-year-old, for COVID-19 immunization; moderna (Dose: 03), administration date: 16Nov2021, when the patient was 65-year-old, for COVID-19 immunization; moderna coviD-19 (red cap booster), mrna (Dose: 04), administration date: 11Jul2022, when the patient was 66-year-old, for COVID-19 immunization; afluria (Dose: Unknown), administration date: 02Oct2019, when the patient was 63-year-old, for Immunisation; fluzone (0.5 ml Prefilled Syringe, Dose: Unknown), administration date: 13Oct2020, when the patient was 64-year-old, for Immunisation; fluzone (High dose > Age 65 (Prefilled Syringe), Dose: Unknown), administration date: 19Oct2022, when the patient was 66-year-old, for Immunisation; fluzone (High dose > Age 65 (Prefilled Syringe), Dose: Unknown), administration date: 22Oct2021, when the patient was 65-year-old, for Immunisation; influenza (Dose: Unknown, Manufacturer: Unknown), administration date: 16Oct2013, when the patient was 57-year-old, for Immunisation; influenza (Dose: Unknown, Manufacturer: Unknown), administration date: 12Nov2014, when the patient was 58-year-old, for Immunisation; influenza (Dose: Unknown, Manufacturer: Unknown), administration date: 31Oct2017, when the patient was 61-year-old, for Immunisation; influenza adult (Dose: Unknown, Manufacturer: Unknown), administration date: 02Oct2019, when the patient was 63-year-old, for Immunisation; influenza adult (Dose: Unknown, Manufacturer: Unknown), administration date: 01Jan2017, when the patient was 61-year-old, for Immunisation; influenza adult (Dose: Unknown, Manufacturer: Unknown), administration date: 01Nov2016, when the patient was 60-year-old, for Immunisation; prevnar 13 (Dose: Unknown), administration date: 15Sep2021, when the patient was 65-year-old, for Immunisation; shingrix (Dose: Unknown), administration date: 07Jun2022, when the patient was 66-year-old, for Immunisation; shingrix (Dose: Unknown), administration date: 25Mar2022, when the patient was 66-year-old, for Immunisation; zostavax (Dose: Unknown), administration date: 12Jan2017, when the patient was 61-year-old, for Immunisation; Influenza adult (Dose: Unknown, Manufacturer: Unknown, (2 more)), for Immunisation. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 14Dec2022, outcome "unknown", described as "Pneumococcal (Pneumovax 23) 14Dec2022"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 14Dec2022 at 11:09, outcome "unknown" and all described as "A multi-dose vial of this vaccine was opened (punctured) yesterday at 2:30 PM and a dose was administered today at 8:44 AM"; CORONARY ARTERY BYPASS (medically significant) with onset 21Dec2022, outcome "unknown", described as "coronary artery bypass graft". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (17Feb2023) 128/79; Body mass index: (unspecified date) 33.0-33.9 adult; Body temperature: (17Feb2023) 97.6 Fahrenheit, notes: 36.4 degree Celsius; Heart rate: (17Feb2023) 70; Hepatic enzyme increased: (unspecified date) Increased; Temp src: (17Feb2023) Temporal; Liver function test: (unspecified date) Elevated; Oestrogen receptor assay: (unspecified date) Positive, notes: Estrogen receptor positive status (ER+); (unspecified date) Positive, notes: Malignant neoplasm of upper-outer quadrant of right breast in female, estrogen receptor positive; Oxygen saturation: (17Feb2023) 99 %; Respiratory rate: (17Feb2023) 16. Therapeutic measures were taken as a result of coronary artery bypass. Additional information: It was reported for Pfizer-BioNTech COVID-19 Vaccine, bivalent gray cap that multi-dose vial of the vaccine was opened (punctured) on 13Dec2022 (reported as yesterday) at 2:30 PM (also reported as 2:13 PM) and a dose was administered on 14Dec2022 (reported as today) at 8:44 AM. Reporter wanted to know stability of the vaccine. The case was reported as non-serious.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (17Mar2023): This is a spontaneous follow up report received from a contactable Other HCP in response to HCP letter. Updated information included: Historical vaccine details, medical history, lab data, past drug, co-suspect drug (added Pneumovax 23), suspect drug details (dose number, lot number, and expiration date), concomitant medications, new events (Coronary artery bypass graft and product use for unapproved combination), and clinical course of events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Reported event coronary artery bypass graft is considered an intercurrent medical condition and is therefore not related to the suspect drug. Case to be re-assessed upon receipt of new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate