Age: 41.0
Sex: F
Vaccine: RSV
Symptoms: Premature labour, Promyelocyte count decreased, Protein urine present, Red blood cell count normal, Red blood cell nucleated morphology present
Clinical narrative: Contractions (Preterm); Maternal Exposure During Pregnancy, third trimester; A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY  This is a Pfizer sponsored study report for protocol. This is the maternal case.   This is a case for a 41-year-old maternal participant, who received study vaccine (PF-06928316; PLACEBO), while pregnant via intramuscular route in left deltoid on 19Jul2021 at 11:23 as single dose, at age of 41-year-old for prevention of respiratory syncytial virus (RSV) in the infant. No adverse events/reactions were reported in the e-diary on 19Jul2021. Participant was not unblinded. Medical history included fibroid from 2019 and ongoing, ongoing uterine fibroids diagnosed from Apr2018 with myomectomy in Apr2018, ongoing uterine fibroids diagnosed from May2019 with myomectomy in 2019, ongoing obesity from Nov2010 with laproscopic band placement and lap band removal in 2010, ongoing allergies (seasonal allergies, birch tree and apples) from 1980, ongoing mild bilateral pedal edema from 2021; pregnancy (C-section) on 12Mar2020, shoulder pain from Dec2008 to Dec2009 with shoulder surgery from Dec2008 to Dec2009, spontaneous abortion (SAB) from 2017 and from 1995. The mother never smoked, used alcohol, or used illicit drugs. Ongoing concomitant medications included fluticasone propionate (FLONASE) for seasonal allergies since 02Apr2021, and minerals NOS/vitamins NOS (PRENATAL VITAMINS) as supplement since Dec2020. There were no concomitant vaccines, prior vaccinations within 4 weeks, or family medical history relevant to the event. Current pregnancy details were as follows: first day of last menstrual period (LMP) was in Nov2020. Gestation at time of initial vaccination was 35 weeks 4 days. The mother had 4 pregnancies with 1 live birth via C-section, 1 elective abortion, 2 spontaneous abortions. The maternal participant experienced contraction (preterm) on 20Jul2021 at 02:00 which was caused hospitalization for less than one day. The clinical course was reported as follows: On 20Jul2021 at 02:00, about 14 hours after IP receipt, the participant woke up with nausea and diarrhea. At 03:00, the participant had abdominal pains, which worsened around 06:00 and she called her obstetrician-gynecologist (OBGYN) who instructed her to go to the labor and delivery suite for further evaluation at 07:06. At 08:37, the participant was admitted to the labor and delivery ward of the hospital (inpatient) with contractions. She presented to triage with complaints of abdominal pain-tightening, coming and going that she found very uncomfortable and thought she was having contractions. No leakage of amniotic fluid was observed, and fetal movements were present. Following evaluations were completed, fetal heart rate assessment: baseline 150, variability moderate and acceleration present. Normal fetal heart rate (FHR) category was: 1. Abdominal assessment: gravid and presentation: vertex. Uterine contractions: tocodynamometer (TOCO)-uterine irritability noted initially, resolved after 1 liter ringer's lactate (RL) and rest. Tests performed on 20Jul2021 included urine analysis which showed +1 protein, +1 ketones. The participant underwent the following laboratory tests and procedures: Basophil count (0.0-0.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Basophil percentage (0.0-4.0): (20Jul2021) 0.1 %, notes: at 11:14; Eosinophil count (0.0-1.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Eosinophil percentage (0.0-7.0): (20Jul2021) 0.3 %, notes: at 11:14; Foetal heart rate: (unspecified date) baseline 150, notes: variability moderate and acceleration present. Normal fetal heart rate (FHR) category was: 1; Haematocrit (37.0-52.0): (20Jul2021) 39.2 %, notes: at 11:14; Haemoglobin (12.0-18.0): (20Jul2021) 12.6 g/dl, notes: at 11:14; Immature granulocyte count (0.0-3.0): (20Jul2021) 0.4 %, notes: at 11:14; TOCO: (unspecified date) uterine irritability noted initially, notes: resolved after 1 liter ringers lactate (RL) and rest; Lymphocyte count (1.0-4.0): (20Jul2021) 0.7 x10 3/mm3, notes: low at 11:14; Lymphocyte percentage (8.0-49.0): (20Jul2021) 7.8 %, notes: low at 11:14; Mean cell haemoglobin (27.0-31.0): (20Jul2021) 28.4 pg, notes: at 11:14; Mean cell haemoglobin concentration (31.0-36.0): (20Jul2021) 32.1 g/dl, notes: at 11:14; Mean cell volume (78.0-94.0): (20Jul2021) 88.5, notes: fL, at 11:14; Mean platelet volume (6.0-11.0): (20Jul2021) 9.2, notes: fL, at 11:14; Monocyte count (0.0-2.0): (20Jul2021) 0.4 x10 3/mm3, notes: at 11:14; Monocyte percentage (4.0-15.0): (20Jul2021) 4.4 %, notes: at 11:14; Neutrophil count (1.0-11.0): (20Jul2021) 7.8 x10 3/mm3, notes: at 11:14; Neutrophil percentage (37.0-84.0): (20Jul2021) 87 %, notes: high at 11:14; Platelet count (140-440): (20Jul2021) 380 x10 3/mm3, notes: at 11:14; Promyelocyte count (0.0-0.3): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Red blood cell count (3.8-5.9): (20Jul2021) 4.4 x10 6/mm3, notes: M/uL, at 11:14; Red blood cell nucleated morphology present (0.0-1.0): (20Jul2021) 0.0 %, notes: at 11:14; Red blood cell nucleated morphology present (0.0-0.0): (20Jul2021) 0.0 x10 3/mm3, notes: at 11:14; Red cell distribution width (11.5-14.5): (20Jul2021) 13.1 %, notes: at 11:14; Urine analysis: (20Jul2021) +1 protein, +1 ketones; Weight: (unspecified date) 129 kg; White blood cell count (4.0-10.0): (20Jul2021) 9.0 x10 3/mm3, notes: at 11:14. Participant was discharged at 11:57 on 20Jul2021. The maternal participant delivered a normal female infant with live delivery, gestational age at birth was 39 weeks, clear amniotic fluid. Apgar scores 1 min and 5 mins were 9. Birthweight was 2.98 kgs, length at birth was 50 cm and head circumference at birth was 33 cm. The action taken in response to the event for blinded study vaccine (PF- 06928316; PLACEBO) was not applicable. The outcome of the event was recovered on 20Jul2021.  The investigator considered there was a reasonable possibility that the event "contractions (preterm)" was related to blinded study vaccine, but unrelated to concomitant drugs or clinical trial procedure.  The blind was broken by sponsor due to serious, related, unexpected event.  Follow-up (30Aug2021): New information reported includes: medical history and pregnancy outcome details.  Follow-up (08Sep2021 and 11Sep2021): New information reported includes: Updated relevant medical history, unblinding status, last action taken as not applicable, and reaction data (updated outcome and date of recovery).  Follow-up (18Feb2022 and 22Feb2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: medical history details (TAB updated to SAB from 1995, myomectomy date updated), reaction data (hospital stay days added), added lab data, additional clinical course (LMP, event details).  Follow-up (04Mar2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: reporter details and medical history (start date of obesity updated to Nov2010).  Follow-up (18Mar2022): This is a Pfizer Sponsored Interventional Study follow-up report for Protocol. Updated information: updated first date of LMP.  Follow-up (15Jan2025): This is a literature report for the following literature source:. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication.   Updated information: Updated Reporter and Literature information. The participant was found to be treated with a single PF-06928316 120 ug dose. It was reported that "premature labor the day after vaccination, which resolved that day after fluids and rest, with uncomplicated delivery at 39 weeks".; Sender's Comments: The event Premature Uterine Contractions is unlisted in the Single Reference Safety Document of the Investigational Product and unrelated to the study drug per company assessment and related per investigator.   Based on the current information available, in a maternal participant with a history of 3 abortions and uterine fibroids, it is the company position that there is not a reasonable possibility study vaccine could have contributed to the event Premature Uterine Contractions. There is not enough evidence available to attribute a causal association between the event Premature Uterine Contractions and the study vaccine. Causality will be further reevaluated based on any additional information during the follow-up  The impact of this report on the benefit/risk profile of the Pfizer PF-06928316; PLACEBO on the conduct of the study 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 Committee and Investigators, as appropriate