Age: 65.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Neutropenia, SARS-CoV-2 test, X-ray
Clinical narrative: led to being Neutropenic; This is a spontaneous report received from a Nurse.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right deltoid for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), on 20Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "insomnia" (unspecified if ongoing); "iron deficient anemia" (unspecified if ongoing), notes: requiring iron infusions-D/T low ferritin levels; "asthma controlled" (unspecified if ongoing); "GERD" (unspecified if ongoing); "diverticulosis" (unspecified if ongoing); "duodenal ulcers" (unspecified if ongoing), notes: anastomosis site from CBS; "osteoarthritis" (unspecified if ongoing); "glaucoma" (unspecified if ongoing); "cataracts" (unspecified if ongoing); "severe intra- abdominal adhesions" (unspecified if ongoing); "obesity" (unspecified if ongoing); "intraabdominal hernias" (unspecified if ongoing); "essential HTN" (unspecified if ongoing); "SVT" (unspecified if ongoing); "cyst right kidney" (unspecified if ongoing); "Brain fog" (unspecified if ongoing), notes: x1 year; "Right trochanteric bursitis hip", start date: 01Jun2020 (unspecified if ongoing), notes: steroid inj. X-rays done ordered MRI; "left knee replacement", start date: 20Oct2020 (unspecified if ongoing); "Covid 19", start date: 13Oct2020 (unspecified if ongoing), notes: Tested positive for Covid 19/ asymptomatic (Tested one day pre-op); "UGI bleed", start date: 25May2020 (unspecified if ongoing), notes: no hospital. Rx Carafate & Protonix; "Large RUQ abdominal hernia", start date: 2020 (unspecified if ongoing), notes: non surgical; "SBO repair hemicolectomy", start date: 07Nov2019 (unspecified if ongoing), notes: Surgical closure of non-healing wound from; "wound", start date: 18Jun2019, stop date: 05Nov2019, notes: Open on healing wound from SBO repair /Chole wound vac X 5 months/Wound debis > Sepsis> Surgery> I&D admitted> wound vac; "severe abd adhesions cholesterol", start date: 06Jun2019 (unspecified if ongoing); "severe abd adhesions cholesterol", start date: 06Jun2019 (unspecified if ongoing); "UGI bleed", start date: 2018 (unspecified if ongoing), notes: anastomosis site from GBS. Duodenal, ADM, given 2 U PRBC; "Bronchitis & Pericardial effusion", start date: 2008 (unspecified if ongoing); "Bronchitis & Pericardial effusion", start date: 2008 (unspecified if ongoing); "Upper mid abdominal ventral hernia along GBS incision", start date: 2004 (unspecified if ongoing), notes: Upper mid abdominal ventral hernia along GBS incision; "Roux-en-Y Gastric Bypass", start date: 2001 (unspecified if ongoing); "Mono/Epstein Barr Virus, pericardial effusion", start date: 2000 (unspecified if ongoing); "Mono/Epstein Barr Virus", start date: 2000 (unspecified if ongoing); "Total hysterectomy", start date: 1994 (unspecified if ongoing), notes: Total hysterectomy w/ Bil oophorectomy-severe endometriosis; "appendectomy", start date: 1992 (unspecified if ongoing), notes: Right ruptured ovarian cyst surgical removal w/ appendectomy; "ORIF Surgery", start date: 1990 (unspecified if ongoing); "Chole wound vac", start date: 18Jun2019, stop date: 05Nov2019, notes: X 5 months; "Wound debis > Sepsis", start date: 18Jun2019 (unspecified if ongoing); "Placenta previa/HTN", start date: 1985 (unspecified if ongoing), notes: Emergent C-section; "Placenta previa/HTN", start date: 1985 (unspecified if ongoing), notes: Emergent C-section; "Toxemia", start date: 1978 (unspecified if ongoing); "HTN", start date: 1978 (unspecified if ongoing); "Seizure", start date: 1978 (unspecified if ongoing); "chronic anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benzine, reaction(s): "swelling"; Niacin, reaction(s): "Hives"; Nsaids, reaction(s): "allergic"; Oral iron, reaction(s): "allergic"; Benzene, reaction(s): "allergic". Vaccination history included: BNT162b2 (Dose: 1), administration date: 09Apr2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose: 2), administration date: 20May2021, when the patient was 63-year-old, for Covid-19 Immunization; BNT162b2 (Dose: 3), administration date: 26Nov2021, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (Dose: 4), administration date: 04Apr2022, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2 (Dose: 5), administration date: 20May2022, when the patient was 64-year-old, for Covid-19 Immunization; BNT162b2, BNT162b2 omi ba.4-5 (Dose: 6), administration date: 21Sep2022, when the patient was 64-year-old, for Covid-19 Immunization; prevenar 13, administration date: 05Jan2023, when the patient was 65-year-old, for Immunization; shingrix (#1), administration date: 05Jan2023, when the patient was 65-year-old, for Immunization; shingrix (#2), administration date: 05Apr2023, when the patient was 65-year-old, for Immunization; Influenza vaccine, administration date: Oct2021, when the patient was 63 years old, for Immunization; Influenza vaccine, administration date: Sep2022, when the patient was 64 years old, for Immunization; Influenza vaccine, administration date: Sep2023, when the patient was 65 years old, for Immunization; Pneumonia vaccine, administration date: 2009, for Immunization; H1n1 vaccine, administration date: 2009, for Immunization; Tdap, administration date: 2012, for Immunization. The patient did not received any other vaccines on the same date as the Pfizer vaccine nor received any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was taking any other medications within 2 weeks prior to the event onset. There were no culture test nor other relevant test performed.  The following information was reported: NEUTROPENIA (medically significant) with onset 19Oct2023, outcome "unknown", described as "led to being Neutropenic". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 63; SARS-CoV-2 test: (13Oct2020) Positive, notes: asymptomatic (Tested one day pre-op); (26Dec2023) Positive, notes: symptomatic; X-ray: (unspecified date) Unknown Results. The information on the batch/lot number for BNT162b2 omi xbb.1.5, rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event neutropenia with BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA) can not be fully excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.